Reporting from the 2021 AAO Annual Meeting
November 12–15, 2021 • New Orleans, Louisiana
- Discussion of same-day bilateral cataract surgery
- DMEK in complex eyes
- Do’s and Don’ts of corneal crosslinking for keratoconus
- Reconstruction of the ocular surface
- Late-breaking developments in retina
- Long-term follow-up with port delivery system of ranibizumab for AMD
Discussion of same-day bilateral cataract surgery
There are several reasons why a discussion about same-day bilateral cataract surgery, or immediate sequential bilateral cataract surgery (ISBCS), is relevant today. Kevin Miller, MD, co-moderator of a session on the topic, cited increasing pressure from governments and private payers and patient preference to spend less time in the healthcare system as a couple of examples.
“All the while, physicians are expected to deliver increasingly better and safer outcomes as payment for their services is reduced repeatedly,” he said.
Kenneth Beckman, MD, discussed who benefits from ISBCS in its current state. He said we are talking about ISBCS because there is increasing demand, patient access issues, a growing aging population, fewer surgeons, and other reasons. Its limitations include risk of infection and other complications, the inability to change decisions for the second eye based on outcomes of the first eye, and reimbursement, which in the U.S. is 50% for the second eye.
Patient benefits from ISBCS include one trip for surgery and fewer postop visits, ease for family members who might be helping with postop regimens, a quicker recovery, one course of anesthesia, and no postop anisometropia.
Surgeon benefits include increasing access to care, getting to more patients, fewer postop visits, and access to new patients. Disadvantages for the surgeons include 50% reimbursement for the second eye, which might not be replaced by the potential for increased volume, and questions about sustainability for a non-salaried surgeon.
Facilities could experience less paperwork and intake work with fewer admissions, reduce some items that would otherwise be duplicated, save room time, and potentially do more cases per day. Dr. Beckman said he’s not sure how much time ISBCS would actually save the facility, so the 50% reduced reimbursement is a major disadvantage.
The third-party payer, Dr. Beckman noted, saves 50% on all second eyes, which is a major advantage for them.
Is ISBCS today an advantage for the surgeon? Possibly but not often, Dr. Beckman said.
Steve Arshinoff, MD, said that ISBCS is an idea whose time has come. He thinks the pandemic accelerated or changed interest in it, but he thinks it would have come anyway. He thinks that ISBCS is better for his patients and has performed 80–90% ISBCS since 1996, losing 15% of his income on the second eye but said he has made up for it with increased volume.
Risk of bilateral endophthalmitis is one of the greatest disadvantages of ISBCS, but Dr. Arshinoff said he analyzed his ISBCS patients (he uses intracameral antibiotics) and found that the risk of bilateral endophthalmitis is 1:17,000. When it comes to adjusting for second eye power, Dr. Arshinoff cited research from Randall Olson, MD, that suggested the benefit of changing for the second eye depends on the instrumentation and equations you use.
“What we need is more biometric accuracy and not adjusting the second eye because you made a mistake in the first,” he said.
Dr. Olson presented the contradicting argument, pulling much of his rationale from a recent editorial by Samuel Masket, MD, published in Ophthalmology (with his permission). The risks for bilateral infection (endophthalmitis, TASS, HORV) might be small, but they are real risks, Dr. Olson said. Just because there is a low incidence does not mean it is as rare as being reported.
He also discussed refractive surprise, noting that the margin for dissatisfaction is getting narrower with the toughest crowd (premium IOLs and post-refractive surgery patients) having the highest desire for refractive perfection. Dysphotopsia, which is rare but associated with some presbyopia-correcting IOLs, is the most common reason for post-surgical dissatisfaction, and it often requires waiting to see how things go before you proceed to the second eye.
The patient needs to understand the small but real risks, Dr. Olson said. However, he did note that some cases might be worth “biting the financial bullet,” such as patients who require general anesthesia or who are coming from rural areas.
Is there such a backlog of patients to make the argument that ISBCS would be a benefit? Shruti Aggarwal, MD, tackled this topic. She shared data that showed there is an increasingly elderly population who need cataract surgery. In addition, the pandemic’s shutdown of non-emergent surgery for a time and other pandemic-related factors created an immediate backlog. Dr. Aggarwal said a simulation analysis modeled the cataract surgery backlog and predicted that even in the most optimistic scenarios, there will be a more than 1 million case backlog at 2 years after the suspension period.
The number of ophthalmologists needed to perform these surgeries is decreasing and the ratio of older to younger ophthalmologists is increasing, Dr. Aggarwal said. She included data from the Department of Health and Human Services that estimated a deficit of 6,000 full-time ophthalmologists in the coming years.
If ophthalmologists decided to do ISBCS, what do they need to do differently? Neal Shorstein, MD, said 60% of his cases are ISBCS, with the financial disincentive being removed at his Kaiser practice. He said you need to “go to extremes to minimize or eliminate adverse events.” He said to read the guidelines, review your own current practices, establish a system with policies and procedures for ISBCS, and perform constant monitoring.
If you have a higher cataract volume, a low complication rate, and are organizationally and process oriented, ISBCS might be a viable option, Dr. Shorstein said. When it comes to the patient discussion, he said it needs to be their choice to do ISBCS and this needs to be documented in the chart. They need to be consented for the risk of vision loss, IOL choice, etc. The surgery center also needs to take a deep dive into its cleaning and sterilization procedures. Dr. Shorstein said medications need to come from a reliable manufacturer, and compounded drugs need to be sourced from a 503-B facility with separate lot numbers being used for each eye. Other items needed for each procedure need to be kept separate as well. Dr. Shorstein said to label IOLs for each eye and even consider keeping the second IOL outside of the room while performing the first eye surgery.
Editors’ note: The physicians do not have financial interests related to their comments.
DMEK in complex eyes
During a cornea session, Nir Sorkin, MD, highlighted DMEK in complex eyes. When surgeons first began to perform DMEK, Dr. Sorkin said most used the technique in simpler eyes. But today, he said it’s technically possible to use DMEK in every eye.
Are DMEK outcomes better in complex eyes? Dr. Sorkin said this is hard to establish because there is no universal definition of a “complex DMEK eye.” The complexity is dependent on surgeon experience and skill. There is also less available data on complex eyes because these cases are less common and highly varied (and there are often several complex features in a single eye).
Dr. Sorkin went on to discuss several types of complex DMEK eyes, including those with previous vitrectomy, aphakia/aniridia, previous glaucoma surgery, and a failed PK graft.
When doing a DMEK with previous vitrectomy, Dr. Sorkin said the anterior chamber does not shallow, it’s hard to unscroll the graft, and graft unscrolling is not maintained.
To overcome this, he suggested several approaches, noting that he has tried using a pars plana infusion to control anterior chamber depth. Early outcomes were promising, he said, but longer-term outcomes saw incidence of retinal detachments.
A double bubble technique could also be used, as could a temporary diaphragm into the anterior chamber to artificially flatten in a temporal fashion. The latter approach has a high detachment rate, but 1-year results saw no failures. Dr. Sorkin noted it would be interesting to see longer-term data.
For now, Dr. Sorkin said that he would choose to do DSAEK in patients with a previous vitrectomy.
For those with aphakia/aniridia, he said a concern is an insufficient lens/iris diaphragm. One option is to use an endothelium-in pull-through technique, but he noted that he would choose to still use DSAEK in these cases at this time.
Previous glaucoma surgery is also a concern in corneal graft surgery. Looking at the use of both DMEK and DSAEK, Dr. Sorkin referenced results that showed initially good outcomes, but survival of grafts declined steeply at 4 years. He also referenced 5-year data that showed suboptimal results with both DSAEK and DMEK in this patient population, with mean graft survival around 3 years. So previous glaucoma surgery, including trabs and tubes, made both DSAEK and DMEK challenging.
With a failed PK graft, Dr. Sorkin said the graft position presents an intraoperative challenge. Graft sizing is also a concern because there can be a high rebubble rate when you oversize the DMEK graft compared to the PK. He said that both DSAEK and DMEK can be used in these patients, but he suggested only considering DMEK if there is good vision potential.
He concluded by saying that DMEK is superior in some complex scenarios, but in other scenarios, the complexity outweighs the benefit. Dr. Sorkin stressed that more studies are needed on this topic.
Editors’ note: Dr. Sorkin has no financial interests related to his comments.
Do’s and Don’ts of corneal crosslinking for keratoconus
Also on the cornea program, Preeya Gupta, MD, highlighted recommendations for using crosslinking to treat keratoconus, noting that crosslinking has become a very important procedure for these keratoconus patients.
First, she said to set realistic expectations. Patients should understand the vision rehabilitation timeline. They can change refractively for 1 year. Patients should also expect to have some pain/discomfort for up to 5–7 days, and Dr. Gupta recommended telling patients to take time off work. BCVA may not be achieved until the patient is stable enough for a scleral lens fitting.
Next, Dr. Gupta spoke about epithelial defect management. Steep corneas may take longer to re-epithelialize and a typical bandage contact lens may not fit well.
She recommended treating aggressively. If not healed by day 7, remove the bandage contact lens and use ointment with or without a patch, and consider an amniotic membrane for a non-healing defect, Dr. Gupta said. Her initial drop regimen includes topical steroid and antibiotic QID.
Haze formation is another consideration. This tends to be in the anterior stroma, unlike PRK-related haze, which is subepithelial, Dr. Gupta said. Increased time to re-epithelialization can increase haze, and most patients get temporary haze. Topical steroids may be needed for a prolonged period. Dr. Gupta said to watch the IOP and to see the patient more frequently.
Infectious keratitis is a “dreaded complication” of epi-off crosslinking. A bandage contact lens may lead to hypoxia and secondary infection. She recommended frequent postoperative checks early on until re-epithelialized. Dr. Gupta also said to culture and treat any infiltrate rapidly. Depending on the location of the ulcer, it can be sight threatening.
Editors’ note: Dr. Gupta has no financial interests related to her comments.
Reconstruction of the ocular surface
Allan Slomovic, MD, focused his presentation on pterygium surgery complications and management. He discussed preoperative, intraoperative, and postoperative considerations in these cases.
For patients who present with a pterygium and cataract, Dr. Slomovic said to do the pterygium surgery first. Then, he said to wait 6–8 weeks until the cornea topography stabilizes. You can then do biometry and phaco.
As far as intraoperative complication management, Dr. Slomovic said, in 2021, pterygium surgery with a conjunctival autograft using tissue adhesives remains the gold standard for managing primary and recurrent pterygia. This significantly lowers recurrence rates, offers better cosmetic results, has a great safety track record, and is cost effective, he said.
Finally, for postoperative complication management and consideration for recurrence, Dr. Slomovic said to consider SLET for patients with more complicated scenarios where conjunctival and limbal sparing technology may not be advantageous. He mentioned these cases might include recurrent pterygium not responsive to conjunctival auto-transplant, large medial and nasal pterygium, and glaucoma patients who may require filtration surgery at some time in the future.
Darren Gregory, MD, discussed ocular surface squamous neoplasia (OSSN), noting that this is an umbrella term that encompasses invasive and noninvasive squamous neoplasia. You often can’t tell just by looking at the patient how deep it has penetrated into the cornea, he said.
Dr. Gregory noted three key characteristic findings of OSSN with high resolution OCT: thickened epithelium, hyperreflective epithelium, and abrupt demarcation between normal and abnormal epithelium.
Editors’ note: Drs. Slomovic and Gregory have no financial interests related to their comments.
Late-breaking developments in retina
Two papers presented in the late-breaking developments section of the retina program looked at novel mechanisms and drug delivery for treatment of wet AMD.
One paper, discussed by Veeral Sheth, MD, covered the ALTISSIMO Phase 2B trial, which evaluated intravitreal sunitinib malate depot (GB-102, Graybug Vision). A 12-month extension study of GB-102 had found that 55% of patients implanted with the 1 mg depot experienced a duration of 12+ months, with maintained visual acuity and central retinal thickness. There was a 73% reduction in injection burden for patients in the extension study. During discussion, Dr. Sheth was asked about particle dispersion, some of which was identified in the anterior chamber in some cases. He said the company is working on newer formulations to reduce the amount of particulate matter.
David Boyer, MD, presented the results of the DAVIO trial, a Phase 1 dose-escalation open-label trial of EYP-1901 (EyePoint Pharmaceuticals) in patients previously treated for wet AMD. There was no control arm for this study. Dr. Boyer described the treatment as an injection of EYP-1901 (vorolanib) in a sustained release, bio-erodible pellet (Durasert). Baseline characteristics of participants were similar to those in other AMD studies with 9 as the median number of anti-VEGF injections prior to the study.
There were no ocular serious adverse events or any drug-related serious adverse events, Dr. Boyer said. Visual acuity and OCT were stable with the treatment. The median time to rescue was 6 months with 76% of patients being rescue-free up to 4 months; 53% were rescue-free up to 6 months. There was a 79% clinically significant reduction in treatment burden, Dr. Boyer said. In terms of continued durability, eight of the 17 eyes in the study were still rescue-free, he said.
Editors’ note: Drs. Sheth and Boyer have financial interests with several ophthalmic companies.
Long-term follow-up with port delivery system of ranibizumab for AMD
In a Retina Subspecialty Day session on neovascular AMD, Peter Campochiaro, MD, presented long-term follow-up data with a port delivery system (PDS) with ranibizumab for AMD. The PDS developed by Genentech/Roche (now called Susvimo) received FDA approval in October. It is a permanent, refillable ocular implant placed at the pars plana, delivering a continuous intravitreal formulation of ranibizumab.
The Archway Phase 3 trial found the PDS 100 mg/ML refilled every 24 weeks was equivalent to monthly ranibizumab 0.5 mg injections, with a BCVA change from baseline at weeks 36/40. Dr. Campochiaro went on to describe the Portal Extension Study, which evaluated the long-term safety and tolerability. Eligible PDS patients from the Ladder and Archway trials were refilled with 100 mg/ML ranibizumab at day 1, and eligible patients from the trials who were initially on monthly ranibizumab received the PDS implant with the initial ranibizumab fill.
Overall, Dr. Campochiaro said the study demonstrated that efficacy was maintained, with stable BCVA from the Ladder baseline to Portal study data cut-off of 48 months after the PDS implantation. About 95% of PDS patients with refills every 24 months did not need supplemental ranibizumab treatment before their next designated refill. From a safety perspective, most adverse events occurred within the first 2 years of follow-up, and most late adverse events occurred earlier in the clinical trial program, prior to optimization of surgical procedures to mitigate these adverse events, Dr. Campochiaro said.
Editors’ note: Dr. Campochiaro has financial interests with several ophthalmic companies.
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