December 2018


EyeWorld/ASCRS reports from the 2018 AAO Annual Meeting

EyeWorld/ASCRS reports from the 2018 AAO Annual Meeting,
October 26–30, Chicago

View videos from the AAO Annual Meeting:

Kevin Miller, MD, discusses late IOL dislocation.

View videos from the AAO Annual Meeting:

David Chang, MD, discusses instrument sterilization and a study testing common practices for this.

View videos from the AAO Annual Meeting:

Eric Donnenfeld, MD, discusses innovations in drug delivery of anti-inflammatories in cataract surgery.

View videos from the AAO Annual Meeting:

Bonnie Henderson, MD, discusses medication prophylaxis for cystoid macular edema and endophthalmitis in routine cataract surgery.

View videos from the AAO Annual Meeting:

Sam Garg, MD, discusses meibomian gland dysfunction and its importance in patients undergoing cataract surgery and refractive surgery.


Better management of unhappy refractive surgery patients

The difference between a good practice and a great practice is the way it handles unhappy patients, said Vance Thompson, MD, Sioux Falls, South Dakota. Dr. Thompson shared pearls at Refractive Surgery Subspecialty Day on how to handle dissatisfied refractive patients but noted that his advice could apply to any unhappy patient. Dr. Thompson spends time listening to his staff’s input on patients preoperatively to help identify those who may have surgical or other challenges. He also will not perform surgery until he feels he has made a personal connection with the patient—and he is upfront with patients when this happens. Although there are various physicians at his practice, all dissatisfied patients must be seen by him. Dr. Thompson encourages physicians to be empathetic when listening and to stay calm. Two preoperative pearls that help at his practice are consistently and repeatedly giving out patient education instructions and handing out a business card with his email and office phone. Dr. Thompson will write his cell phone on the card, a move that patients seem to appreciate.

Editors’ note: Dr. Thompson has no financial interests related to his presentation.

When to use PRK, LASIK, or SMILE

Laser vision correction is faster and has better nomograms compared to 15 or 20 years ago, said Jodhbir Mehta, MD, Singapore. Surgeons now have two decades of data on PRK, high patient satisfaction with LASIK, and a growing amount of data on SMILE (Carl Zeiss Meditec, Jena, Germany). That said, each procedure has its idiosyncrasies, and Dr. Mehta shared a chart to help indicate when he selects one procedure over another. For instance, PRK is his top choice for a nervous patient, followed by LASIK, then SMILE. For a patient at risk for dry eye, PRK and SMILE are his top choices, with LASIK in third place. In a patient with moderate to high myopia, Dr. Mehta leans toward SMILE, while PRK and LASIK are equally ranked after that.

Editors’ note: Dr. Mehta has financial interests with Carl Zeiss Meditec.

Updates on the Cornea Preservation Time Study (CPTS)

During the Cornea and Eye Banking Forum, several presenters gave updates on the Cornea Preservation Time Study (CPTS). Jonathan Lass, MD, Cleveland, presented “Predictive Factors for Graft Dislocation and Outcomes After DSAEK in the Cornea Preservation Time Study.”
Dr. Lass highlighted several messages from the primary CPTS papers on graft success. Preservation time up to 11 days had little influence on graft success after 3 years following DSAEK, and there was a 94% success rate. 
The objective of the study Dr. Lass discussed was to examine the donor, recipient, and operative factors associated with graft dislocation and the consequences in regard to graft success and endothelial cell density (ECD) 3 years after DSAEK. 
Graft failures could be early or late, Dr. Lass said, and he detailed the two types of graft malpositions examined (graft dislocation and partial detachment).
There were graft dislocations in 104 of 1,330 (8%) eyes, and of the 104 eyes, 98 had an air injection. 
For air injections, 152 of the eyes without graft dislocation had at least one occurrence of interface fluid. Of these eyes, 41 (27%) had air injections (39 with one injection, one eye with two injections, and one eye with three injections). He added that 111 eyes (73%) had interface fluid but no air injection.
Dr. Lass said significant factors associated with graft dislocation include operative complications, donor history of diabetes, and a donor cornea with thicker precut thickness. He also discussed the impact of graft dislocation with graft failure in the CPTS. Eyes with graft dislocation had an eight times increased risk for failure through 3 years compared with eyes without graft dislocation. There was a 66% success at 3 years with dislocation vs. 96% without graft dislocation. 

Editors’ note: Dr. Lass has no financial interests related to his presentation.

Anterior segment imaging

During a session at Cornea Subspecialty Day, Elmer Tu, MD, Chicago, discussed diagnostic imaging in infectious keratitis. 
Bacterial keratitis is generally discrete “colony” lesions and there’s usually inflammation. 
Meanwhile, clinical signs of fungal keratitis may include minimal necrosis, minimal inflammation, a growth pattern that includes branching filaments (punctate “on end” opacities and additive to the corneal contour), satellite lesions, and a feathery, irregular margin. Dr. Tu said to watch out for the sudden onset of or worsening of hypopyon because that could indicate fungal keratitis, as could penetration of fungal elements into the anterior chamber. Any pigmentation strongly suggests a fungal etiology, Dr. Tu said. 
Dr. Tu highlighted culture methods before moving on to discuss how optical coherence tomography (OCT) may help identify infectious keratitis. He noted that OCT has a limited ability to identify organisms but may be useful in special cases, like CMV endotheliitis or retrocorneal plaque assessment. 
The “gold standard” is confocal microscopy, Dr. Tu said, which is an alternative to corneal biopsy and offers real-time imaging. He noted that bacterial keratitis is not easily imageable because the bacteria are so small. Corneal morphology can be imaged, and atypical infectious keratitis will be the greatest utility for confocal microscopy.

Editors’ note: Dr. Tu has no financial interests related to his presentation.

Topics in keratoplasty

A section of the Cornea Subspecialty Day program highlighted a variety of keratoplasty topics. Mark Mannis, MD, Sacramento, California, presented “Perfecting Penetrating Keratoplasty: Lessons Learned Over Time.” Though there has been a shift to endothelial keratoplasty (EK), Dr. Mannis said that surgeons still need to know how to do penetrating keratoplasty (PK). He noted that PK “still dominates outside North America.”
Dr. Mannis highlighted several instances when PK is still necessary, particularly in pan-layered corneal disease and therapeutic keratoplasty (infection, trauma, or in regions of the world with significantly advanced disease).
Signature skills for PK include patient selection, open sky management in the OR, suturing skills, refractive management, immunomodulation, and glaucoma management.
Dr. Mannis said surgeons should take certain preoperative considerations, especially making sure to optimize the ocular surface. Choice of anesthetic and knowing your eye bank are also important factors preoperatively. 
Intraoperatively, Dr. Mannis said establishing a team approach, having a speculum of choice, being prepared for the worst complication, and operating with refraction in mind are all important. 
Finally, he highlighted postoperative considerations. These include patient education, close monitoring of IOP, simplification of medical management, patient prep, and knowing when “enough is enough.”
Mark Terry, MD, Portland, Oregon, discussed the challenge of transitioning to DMEK.
DMEK today is easier and faster with standardization of techniques, he said, noting that eye banks now take several steps to help eliminate some complications prior to surgery. Tissue is now prestripped, eliminating the risk of the surgeon destroying tissue at the time of surgery. Tissue is prestamped, which helps eliminate the risk that it would be inserted upside down, and it is preloaded.
DMEK requires a different skill set than DSAEK. The DMEK scroll always spontaneously rolls up with endothelium on the outside of the scroll, so touching the tissue directly kills endothelium, Dr. Terry said, adding that donors over 60 years old tend to be thicker and are easier to unscroll. 
Dr. Terry then described two variations in DMEK tissue injection: endothelium-out and endothelium-in. The endothelium-out technique (natural scrolling conformation of the tissue) is a tapping method of opening the tissue. Meanwhile, endothelium-in (tissue folded over viscoelastic) is a pull-through method with an anterior chamber maintainer.
For surgeons looking to take the first steps in learning the DMEK procedure, Dr. Terry recommended attending didactic and wet lab courses, viewing videos online on DMEK, and understanding the variations in DMEK techniques and unique challenges of each. He added that the most important step is to “be the first assistant at the microscope with an experienced DMEK surgeon.” This will help a surgeon learn the nuances of the surgery before doing his or her first case. 
Dr. Terry also offered advice on how to make your first DMEK cases easy. Start with DMEK in a Fuchs’ dystrophy eye that is already pseudophakic. Avoid eyes with prior vitrectomy, an AC IOL, large iris defects, tubes, or trabeculectomies; request tissue that is 60 years or older; start with preloaded tissue; use SF6 if it is easily accessible; and learn to rebubble at the slit lamp to have minimal disruption in your clinic.

Editors’ note: Drs. Mannis and Terry have no financial interests related to their presentations.

Action for CyPass Micro-Stent on track

The voluntary withdrawal of the CyPass Micro-Stent (Alcon, Fort Worth, Texas) from the market in late August due to endothelial cell loss data over a 5-year period was a shock to ophthalmology. However, Thomas Samuelson, MD, Minneapolis, president of ASCRS, thinks the moves underway to research what occurred with the CyPass are on the right track. “In my opinion, the process is working,” he said. ASCRS formed a task force that includes members from the organization’s Cataract and Glaucoma Clinical Committees. The task force recommends informing patients about the market withdrawal, examining and performing gonioscopy, and documenting the position of the device. Some patients may need more frequent monitoring. “Hopefully, Alcon can partner with the FDA to bring this [device] back to a more suitable population,” Dr. Samuelson said.

Editors’ note: Dr. Samuelson has financial interests with Alcon.

Debating the femtosecond laser 

During the “Cataract Controversies on Trial” session, presenters made point/counterpoint arguments on several topics. Brandon Ayres, MD, Philadelphia, and Zaina Al-Mohtaseb, MD, Houston, advocated for and against, respectively, the use of the femtosecond laser in cataract surgery.
Dr. Ayres argued that “FLACS will bring people flocking.” For the past several years, we have had access to femto to help with cataract surgery, he said. The first femtosecond laser was approved in 2010, and now there are five different lasers. 
What will make doctors/patients flock toward the laser?
Dr. Ayres first highlighted safety. Multiple publications support the safety of the FLACS procedure. Experience and technology improve outcomes, he added. Dr. Ayres said there is a reduced amount of ultrasound energy used, safety in training institutions has been established, and it may be safer than conventional surgery in the trained hand. 
Dr. Ayres continued by discussing the capsulotomy in femto surgery. There is better consistency in size and shape with better initial IOL centration and improved refractive results with the laser, he said. There is also a reduced use of OVD, better centration, and reduced use of capsular stain. In non-human tests, Dr. Ayres said, the capsulotomy strength has been shown to be stronger than a manual rhexis. 
Ultrasound energy was another area that Dr. Ayres pointed to in order to show the benefits of the femtosecond laser. It reduces the energy needed for lens removal, and some studies seem to show it is safer for the endothelium and causes less corneal swelling after cataract surgery. Dr. Ayres also pointed to studies showing reduced cell loss in patients with Fuchs’ endothelial dystrophy, though not all studies showed this. 
Finally, Dr. Ayres highlighted points on astigmatism management, noting no difference in surgically induced astigmatism with manual vs. laser incisions. Laser-created arcuate incisions may be more accurate than manual LRI, and it is as effective as a toric IOL for low amounts of astigmatism. Dr. Ayres said that treatment of astigmatism is reliable with the laser, but there is no single nomogram that exists for treatment. The laser does have the advantage of being able to make intrastromal arcuate incisions. Also on the topic of astigmatism management, Dr. Ayres said that the majority of laser platforms have some tracking and planning software, and image-guided systems help to reduce the dependence on manual marks. Intrastromal marks can be made with the femtosecond laser, he said.
On the other side of the argument, Dr. Al-Mohtaseb argued that “FLACS will die a slow death,” showing study data to support her claim. The laser came out in 2010, and in 2017, market data showed that it has only penetrated about 24%. 
She then delved deeper into the literature on safety data. There is statistical significance to show that there are actually more complications compared to manual. 
Dr. Al-Mohtaseb said that femto seems to show higher postoperative complication rates. Usually, you would pick your “best cases” for femto, she said, particularly premium cases and those that are less complicated. 
Is the femtosecond laser cost effective? Dr. Al-Mohtaseb argued that it’s not. She pointed to published data from John Berdahl, MD, that indicated the laser costs more than $400,000, and utilization costs are about $70,000 per year. With that, you would have to do a large number of cases to just break even, she said. 
Following arguments from Dr. Ayres and Dr. Al-Mohtaseb, a panel weighed in on the topic as well. Elizabeth Yeu, MD, Norfolk, Virginia, argued that some of the data published was from earlier generation femto platforms. With advancements, there are certainly refractive advantages of using the laser, she said. 
Dr. Yeu added that lens softening and fragmentation patterns have improved and use a reduced amount of ultrasound energy, which is safer for the cornea. 
Randall Olson, MD, Salt Lake City, said there has been a lot of potential for the femto laser, but studies just haven’t supported this. It’s hard to see any advantage in outcomes and complications, he said. 
Dr. Olson thinks that femto is about the same as manual. He said there are two certainties: FLACS takes more time, and it’s more expensive. He also said that femto could cause a problem if surgeons depend too much on the laser to do cases that are beyond their learning curve and then don’t know what to do if complications arise. “You have to be as good with manual as you are with femtosecond,” he said. It’s a mistake to assume that femtosecond is going to “do it all,” he said. 
Dr. Ayres reiterated that he loves his laser and said that he does both manual and femto cases. He thinks that lasers haven’t been given enough time yet, but he admitted that he doesn’t think femto lasers will stay the way they are now. 
Audience members ultimately agreed with Dr. Al-Mohtaseb, with more than two-thirds agreeing that they think femto will “die a slow death.”

Editors’ note: Dr. Ayres and Al-Mohtaseb have no financial interests related to their presentations.

Managing complications

The popular “Ophthalmic Premier League” session was back again, with presenters sharing videos cases of complicated cases. 
Susan MacDonald, MD, Boston, discussed how to manage vitreous loss. Vitrectomy is actually a simple and straightforward procedure, she said. There are steps and equipment that you need, but it can be completed by all cataract surgeons once you understand it. The problem, she said, is that when it’s unexpected, it can be anxiety inducing for surgeons. 
Dr. MacDonald first stressed the importance of pressurizing the chamber and taking your hand off the eye.
She spoke about the importance of injecting triamcinolone into the anterior chamber, which “allows you to see exactly what you’re doing.”
Dr. MacDonald said it’s important to create a closed system (where the pressure is not fluctuating) and to remove the vitreous without pulling on it. She prefers to use a pars plana approach. If you don’t feel comfortable doing a pars plana anterior vitrectomy, Dr. MacDonald recommended going to a wet lab to become more proficient in this technique.

Editors’ note: Dr. MacDonald has financial interests with Perfect Lens
(Irvine, California) and ianTECH (Reno, Nevada).

Dry eye requires individualized treatment

Moderate to severe dry eye disease is equivalent to a disabling hip fracture or severe angina in terms of quality of life, said Bennie Jeng, MD, Baltimore, who shared dry eye advances during the “Hot Topics of the Ocular Surface” session. Treatments for dry eye have evolved significantly, and ophthalmologists should focus on treating the underlying cause of dry eye and not just the symptoms, Dr. Jeng said. Sometimes this means having patients stop the use of medications that add toxicity to the ocular surface. Although punctal plugs are an option for some dry eye patients, Dr. Jeng does not like to use them until the ocular surface health improves. Many patients have dry eye caused by blepharitis, and that’s when Dr. Jeng focuses on treatments that provide patients the most comfort. However, he also said treatment for blepharitis is not needed until the patient is symptomatic or if the patient needs his or her ocular surface optimized for surgery. It’s important to let patients know that there is no real cure for blepharitis, he added. For meibomitis, consider culturing, eyelid wipes, and dietary supplementation. In more severe patients, serum, plasma, and scleral lenses can be part of the treatment mix. 

Editors’ note: Dr. Jeng has no financial interests related to his comments.

The latest and greatest in cataract surgery

“Cataract Surgery: The Cutting Edge” provided a roundup of the latest advances in cataract surgery, moderated by Robert Osher, MD, Cincinnati. 
Warren Hill, MD, Mesa, Arizona, spoke about available IOL formulas and advised attendees to use the newer Olsen, Barrett, or Hill-RBF formulas. However, the addition of the Wang-Koch axial length adjustment to the calculations has helped improve the other formulas as well. 
Edward Holland, MD, Cincinnati, shared a variety of new and upcoming treatments for cornea, including two new types of cyclosporine, the newly approved Oxervate (cenegermin, Dompé, Milan, Italy) for neurotrophic keratitis, new drug delivery systems, an artificial endothelium under development, cultured endothelial cell injection therapy, and even a 3-D printed cornea. 
Glaucoma is also having a renaissance for its medication options, said Richard Lindstrom, MD, Minneapolis. The nitric oxide-releasing prostaglandin Vyzulta (latanoprostene bunod, Bausch + Lomb, Bridgewater, New Jersey) was recently approved, along with the rho kinase inhibitor Rhopressa (netarsudil, Aerie Pharmaceuticals, Durham, North Carolina). There are other glaucoma agents in Phase 2 and 3 trials, including a punctal plug that delivers medication and a bimatoprost ring, Dr. Lindstrom said.

Editors’ note: Drs. Hill, Holland, Lindstrom, and Osher have financial interests with various ophthalmic companies. 

Cataract complications

A spotlight session focused on a variety of cataract complications, with presenters sharing videos of issues they encountered. Cases examined posterior polar cataracts, white cataracts, zonular dialysis, wrong IOL power, shallow anterior chamber, and more. 
Richard Hoffman, MD, Eugene, Oregon, shared a case where he had problems with a decentered lens. 
He presented a bimanual case where he injected an IOL with no resistance. The lens was centered at the end of the procedure, but at postop day 1, he noticed that the IOL was decentered in the bag, despite the patient being asymptomatic. Thinking it would be an easy fix, Dr. Hoffman reopened one of the bimanual incisions and repositioned the lens. However, he noticed that it still wasn’t centering. He then decentered the lens temporally so it would slide back into a central position when it decentered. 
Still not satisfied, Dr. Hoffman rotated the lens 90 degrees, and as he was rotating, he noticed that something was “not quite right.”
The problem, he said, was that half of the haptic was missing. He used intraocular scissors to remove the lens, ultimately going through the main incision. He took the lens out without difficulty but could not find the missing piece of the haptic. 
Dr. Hoffman removed the viscoelastic, doing a meticulous 5-minute removal in hopes of finding the missing haptic fragment. However, he still couldn’t find it. Dr. Hoffman then injected viscoelastic and placed a three-piece lens in the bag. The lens was inserted with no problem, and he removed the viscoelastic (and was still unsuccessfully trying to find the haptic fragment). 
After referencing the original surgical video, Dr. Hoffman realized that the fragment was either left in the injector or never came with the lens (but it was not in the eye). 
Dr. Hoffman stressed that if the fragment had been in the eye, it would have been crucial to find it because he had dealt with another case where a sliver of the original lens after an IOL exchange was left in the eye and caused corneal decompensation. 
Dr. Hoffman concluded by offering key tips from this case. If the IOL won’t center, it’s usually from haptic damage. But it could also be caused by capsular bag or zonular compromise or vitreous prolapse. 
If you have a torn haptic or missing piece, you want to find and remove the fragment, or document that the fragment was never injected into the anterior chamber.

Editors’ note: Dr. Hoffman has financial interests with Alcon (Fort Worth, Texas) and MicroSurgical Technology (Redmond, Washington).

Managing weak zonules

Robert Cionni, MD, Salt Lake City, gave the Kelman Lecture on “Dealing with Damaged Zonules.”
There’s no doubt that when challenged with weakened zonules, we have an unmet need, he said, adding that 20 years ago, there was a tremendous unmet need.
In ancient times, when couching was the preferred method for cataracts, weak zonules were a blessing because you could drop the nucleus into the back of the eye, Dr. Cionni said. It wasn’t until the advent of extracapsular surgery and phaco that we wanted to maintain strong zonules to support an IOL, he said, adding that phaco is challenging with weakened zonules. 
Viscoelastic devices allow physicians to maintain a stable chamber, Dr. Cionni said. Additionally, capsulorhexis, hydrodissection, and the advent of the femto laser have aided in these challenging cases, as do capsular hooks and tension rings.
Dr. Cionni shared some of the general principles of zonular management:
• Never let the chamber collapse.
• Complete the CCC (make it larger than normal to be able to manipulate the nucleus more easily).
• Use generous hydrodissection.
• Use generous OVD for expanding the capsular bag and manipulation of the nucleus and cortex.
• Use stable-chamber phaco and I&A techniques.
• Hooks, rings, and segments are very valuable.
Dr. Cionni highlighted when a CTR is required and at what point during the procedure it should be placed (“as late as you can but as soon as you need it”). He discussed the advent of his Cionni ring, as well as modifications other surgeons have made to his ring. Dr. Cionni noted that over time, he has learned the Prolene sutures are no longer recommended (and he has spent much time fixing these sutures that have broken over the years). He recommended using Gore-Tex sutures, though noted that this is off-label.

Editors’ note: Dr. Cionni has financial interests with Alcon and Morcher
(Stuttgart, Germany).

ASCRS symposium 

A symposium co-sponsored by ASCRS focused on “Refractive Cataract Surgery for the Comprehensive Ophthalmologist.” The session was chaired by Edward Holland, MD, Cincinnati, chair of the ASCRS Program Committee, and Vance Thompson, MD, Sioux Falls, South Dakota, EyeWorld Refractive editor. 
Panelists at the session included Blake Williamson, MD, Baton Rouge, Louisiana, Preeya Gupta, MD, Durham, North Carolina, Elizabeth Yeu, MD, Norfolk, Virginia, John Berdahl, MD, Sioux Falls, South Dakota, and William Wiley, MD, Cleveland. 
Kerry Solomon, MD, Mount Pleasant, South Carolina, presented on how to have satisfied customers, build your practice, and develop a true cataract refractive practice. He noted that new technology, great outcomes, a compassionate and caring office culture, and a focus on customer service are all important factors. Dr. Solomon tracks outcomes at his office, and he prioritizes customer service, customer satisfaction, elective products, and surgical outcomes. 
Dr. Solomon said it’s important to meet with and empower staff. He stressed that learning to work as a group, including doing team building exercises, is an important part of his practice.
Dr. Solomon said to “develop a refractive cataract mindset.” This includes developing refractive packages for your practice. He added that enhancements are a part of refractive cataract surgery, and it’s important to address the possibility with the patient prior to surgery. 
Dr. Solomon also mentioned incorporating advanced technology into your practice, holding yourself accountable to metrics, and keeping your practice website up to date.
Sumit “Sam” Garg, MD, Irvine, California, spoke about patient education and informed consent. Cataract surgery is refractive surgery, he said, mentioning the importance of preop evaluation, discussing patient expectations, discussing realistic goals, and doing a comprehensive exam. Dr. Garg shared four ways of improving the informed consent process:
1. View informed consent as an educational process rather than a legal document.
2. Educate and maximize input from office staff. 
3. Draw from lessons learned in refractive surgery. 
4. Utilize valuable reference materials. 
To improve the informed consent process, Dr. Garg pointed to comprehension, competence, and speaking in lay terms. He said to make sure a patient understands what you said, and also make sure he or she is able to decide on a plan. Use an interpreter if necessary. 
Dr. Garg said he likes to use questionnaires and added that you should know both what your patient wants and what he/she doesn’t want. It’s important to remain meticulous with preoperative procedures. 
Relating to educating and maximizing input from office staff, Dr. Garg said that this could involve discussion, your website, videos, and vision simulators. 
When drawing from lessons learned in refractive surgery, Dr. Garg said it’s important to have an active dialogue with the patient. He encourages family members to attend appointments. It’s a good idea to gauge the patient’s personality and expectation level, provide him or her with the options for treatment, and explain the potential risks and complications. 
Finally, Dr. Garg discussed utilizing valuable reference materials and tools. These could include books and other procedure-specific consent information. 
You want to personalize to your patient, he said. Be honest about the incidence and occurrence of complications, and don’t promise a particular visual outcome. It’s also important to personalize risks. 

Editors’ note: Drs. Solomon and Garg have no financial interests related to their presentations.

Ethics of clinical research

“The Future of Cornea in 3-D: Drugs, Devices, and Diagnostics” symposium was co-sponsored by the Cornea Society and Sektion Kornea of the German Ophthalmological Society (DOG). 
This symposium featured the Castroviejo Lecture on “The Ethical Basis of Clinical Research” given by Alan Sugar, MD, Ann Arbor, Michigan.
Dr. Sugar started with some background in the history of clinical research, noting several “scandals” in clinical research, including the Nazi experimentation in World War II and the Tuskegee Syphilis Study in the U.S. He also noted several scandals in ophthalmology, including the Tampa Trephine, which was a new device to cut donor cornea, approved for animal study and approved for clinical trial (though no patients enrolled), and data was presented at AAO in 1995. However, 60+ patients were treated outside of trial, without consent.
Dr. Sugar went on to discuss ethical standards, reports, and ethical principles developed, often as a result of some of these scandals.
The Belmont Principles became the principles of ethics in the U.S., and the three principles are autonomy, beneficence, and justice. The Belmont Principles have had an influence on clinical practice, applicability to non-research patient care (as well as research patient care), and recognize the decline of medical paternalism. 
He spoke about Federal law requires registration of trials, and summary results must be reported after FDA approval. That database includes almost 300,000 trials from around the world. 
Dr. Sugar discussed surgical innovations, physicians’ conflicts of interest with treatment and research, and increasing public awareness. 
In conclusion, Dr. Sugar said that clinical research is an essential part of improving patient care. Ethical issues are complex and critical. Consider these issues when designing studies and reading study reports. He also said that there is a need for systematic study to better understand and resolve these ethical issues in ophthalmology and to consider these issues in all clinical care.

Editors’ note: Dr. Sugar has no financial interests related to his presentation.

EyeWorld/ASCRS reports from the 2018 AAO Annual Meeting EyeWorld/ASCRS reports from the 2018 AAO Annual Meeting
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