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American Academy of Ophthalmology
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November 13, 2021
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The 2021 meeting of the American Academy of Ophthalmology is under way; here are a few highlights so far!
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Phase 2 Clinical Trial to Evaluate the Efficacy of Phentolamine Ophthalmic Solution and Low-Dose Pilocarpine for the Treatment of Presbyopia
The Phase 2 VEGA-1 trial evaluated 150 presbyopic patients across 17 U.S. clinical sites for moderate use of iris dilator and iris sphincter muscles to improve near vision. At visit 1, subjects were randomized to receive phentolamine ophthalmic solution (POS), or placebo drops, taken at night at home. At visit 2, subjects received either low dose pilocarpine (LDP), or no treatment, and efficacy and safety data was collected. The primary endpoint was percent of subjects with greater than or equal to 3 lines improvement in distance corrected near visual acuity comparing POS+LDP vs placebo alone at one hour. VEGA-1 met the primary endpoint, with statistical significance for binocular photopic near vision at 1 hour. 61% of the POS+LDP group gained 3 lines or more vs. 28% placebo. It also met the co-primary endpoint vs. placebo, gaining 3 lines near vision with less than 5 letters distance vision loss against individual components at multiple timepoints. Several key secondary endpoints were also met, including rapid onset at 30 minutes and durable near vision improvement through at least 6 hours. The safety profile for POS+LDP was favorable; there were no serious adverse events, and no headache, brow ache, or blurry vision was reported.
Presbyopia Correction With Refractive IOLs: Pearls and Pitfalls
The surgical goals in using IOLs for presbyopia correction include excellent vision, high patient satisfaction, reduction or elimination of astigmatic error, and avoidance of night vision complaints. Pearls that were shared in this session are that preoperative testing is very important, as is setting proper expectations for the patient. And it’s important to select the optimal strategy–either a range of vision IOL, or monovision. These strategies include a trifocal or bifocal IOL, which balances range of vision vs. night vision complaints; monovision, for which toric or monofocal IOLs can be used (the distance eye is critical here, and for the near eye a neutral aspheric or non-aspheric should be used); and the Light Adjustable Lens, which has the advantage of being adjusted postoperatively. With the right selections, presbyopic IOLs can deliver excellent visual results, but it needs to be remembered that even the perfect patient may not achieve complete satisfaction with presbyopic IOLs. |
Comparative Outcomes in Refractive Lens Exchange: Bilateral Extended Depth of Focus IOL vs. Mix-and-Match Approach in Emmetropic Presbyopic Patients
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| Extended depth of focus (EDOF) IOLs perform better at both far and intermediate distances. Multifocal IOLs perform better at far and near distances. A mix and match approach has been proposed by some studies to take advantage of each type. This study looked at presbyopic patients with axial length between 22 and 24 mm who had bilateral clear lens exchange. Subjects were divided into an EDOF only group, who received bilateral EDOF IOL implantation, and a mix and match group, who received an EDOF IOL in the dominant eye and a multifocal IOL in the fellow eye. At a 3-month postoperative visit, visual outcomes with corrected (CDVA) and under-corrected (UDVA) far and near visual acuity and refractive outcomes were assessed. Both groups had CDVA and UDVA at far and near distances of 20/20. Visual outcomes were similar in both groups. Both groups had a high level of visual satisfaction, and the authors observed similar results in visual acuity both at far and near in both groups. The authors note the study was limited by a small sample size, and they are working on a larger database, taking more variables into account. |
Presbyopia Correction in the Plano Presbyope
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| Treating the plano presbyope can be one of the most difficult types of cases. Patients with clear lenses are used to excellent distance vision, and even with lens dysfunction or opacity they’re not used to wearing glasses. They are less likely to accept compromises in quality of vision or residual refractive error. The challenge is to reduce intermediate and near spectacle dependence without compromising distance and quality of vision. There are cornea-based (one eye) and lens based (one or both eyes) solutions. For a single eye, clear lens, procedures include monovision, laser blended vision, intracorneal inlay, and conductive keratoplasty. For single or both eye procedures, approaches include a presbyopia-correcting IOL (an EDOF lens for increased range of focus and trifocal or a hybrid for full range of focus), a presbyopia phakic IOL (the IPCL), and pharmacological therapy (miotic and lens softening agents are being investigated). For corneal surgery, patient selection is critical, a contact lens trial should be done first (laser blended vision has been shown in one study to provide better results than contact lenses), a clear explanation of benefits and compromises should be given, and the far distance eye needs to be perfect. For lens surgery, it’s an easy decision to do this if the lens is dysfunctional or cloudy but still controversial if the lens is clear. The choice of presbyopia-correcting IOL is a key element, and the refractive target has to be achieved. |
Presbyopia Correction in the High Myope
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| Phakic IOLs (pIOLs) have been an established method for correction/reduction of myopia for many years. The proven safety and efficacy have lead to the development of presbyopic options; however, there currently is no pIOL FDA approved for presbyopia correction. One such lens in development is the Staar EVO Viva Implantable Collamer lens, with aspheric optic. This lens has received CE mark, but is not approved in the U.S. It is indicated for the correction/reduction of myopia with presbyopia ranging from -0.5 D to -20.0 D at the spectacle plane. A prospective, multicenter open-label clinical study was performed and the results published. In the presenter’s experience, it’s important to first investigate the posterior segment, but in the appropriate patients the lens works. Patients selected should have a need for both distance and near correction, and should receive counseling after their early postoperative experience. |
Today is just the beginning, there’s plenty more to come!
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