Carolina Eyecare Physicians

To evaluate outcomes after implantation of two extended depth of focus IOLs, with emphasis on performance in dim light. Two clinical practices in the USA. Prospective, double masked, randomized clinical trial. Subjects were randomized to receive Symfony Optiblue or Vivity IOLs. Objective optical quality, aberrations, and simulated visual disturbances were measured before and 3 months after surgery. Binocular visual acuity (VA), the defocus curve and low contrast VA were measured under mesopic lighting conditions. Patient questionnaires were administered and undirected patient comments were recorded. Thirty-one subjects in each group completed the study. Refractive outcomes were not significantly different. The Symfony lens provided about a half line better monocular mesopic VA at distance when uncorrected and best corrected (p < 0.05). There were no differences in binocular visual function between lenses except for the mesopic defocus curve at -1.00 D and -1.50 D, with the Symfony lens providing better VA at those vergences (p < 0.02). Objective optical measures improved after surgery, with improvements not different by group. There were no differences in the size or intensity of simulated glare, but simulated halos and starburst size and intensity were significantly worse with the Symfony lens (p < 0.05). Satisfaction with distance and intermediate vision in both groups was high. Reported visual disturbances were not significantly different between groups. The two lenses provided similar visual performance in dim light, with the Symfony lens showing slightly better VA, but with more reports of halos and starbursts.

PurposeTo objectively determine if angle kappa materially influenced clinical outcomes or patient-reported satisfaction and visual quality of patients implanted with a trifocal intraocular lens (IOL).MethodsThis was a non-interventional study of clinical outcomes. Subjects were patients choosing to be bilaterally implanted with a trifocal IOL (PanOptix®) who were then evaluated 3 months postoperative. Angle kappa (AK) was measured before surgery and at the 3-month visit. The 3-month visit included a manifest refraction, and measurement of uncorrected and distance corrected acuity at 4 m, 60 cm and 40 cm. Visual quality and satisfaction questionnaires were also administered.ResultsData from 56 eyes of 28 subjects were analyzed; 26 eyes had an AK magnitude <0.3 mm, 14 had an AK from 0.3 mm to less than 4 mm and 16 had an AK ≥0.4 mm. Neither visual disturbances (eg, glare, halos, starbursts), satisfaction nor spectacle dependence were correlated to the magnitude of angle kappa. The magnitude of postoperative AK was significantly lower than preoperative (0.24 ± 0.12 mm vs 0.30 ± 0.16 mm, p < 0.01).ConclusionThe magnitude of preoperative Angle Kappa had no apparent effect on the refractive, visual acuity or subjective (visual disturbances, quality of vision, satisfaction) clinical outcomes with this trifocal IOL. The magnitude of angle kappa was significantly lower after surgery.

Our profound thanks to Professor Grzybowski for bringing to light the important issue of placebo-controlled trials in ophthalmology. I could not agree more that a noninferiority trial is superior to a placebo-controlled trial whenever possible. Our number 1 obligation is always to the patient, which is best preserved in a noninferiority trial. For this reason, vision-threatening diseases such as glaucoma and macula degeneration use a noninferiority design with an active comparator such as topical timolol in glaucoma trials. In studies of inflammation that evaluate corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immunomodulators for dry eye, the most common study design is a placebo-controlled trial. In fact, of the over 100 clinical trials of ophthalmic corticosteroids, NSAIDs, and dry-eye treatments, we are only aware of 2 clinical trials that were of a noninferiority design.1,2 There are two major reasons for this convention. The first reason is that the short-term occurrence of inflammation in these studies has not been associated with long-term vision loss. Rescue medications are readily available to patients at the discretion of the clinical investigator. The second reason applies to the United States and corresponds to the U.S. Food and Drug Administration (FDA) approval process. Placebo-controlled trials are more likely to demonstrate statistical significance, leading to FDA approval of a medication and patient access to new therapies. The profound time, cost, and effort that goes into obtaining FDA approval of an anti-inflammatory medication or delivery systems, such as the nepafenac punctal plugs we evaluated in our study, make noninferiority trials risky for the companies involved. They may also delay patient access to new therapies compared with placebo-controlled trials in gaining an FDA approval. Unfortunately, despite Professor Gzbowski's accurate concerns, until the FDA approval process is modified, we will continue to perform placebo-controlled trials for the greater benefit of our patients.

As the population ages, the number of patients presenting to ophthalmologists with complaints of double vision is increasing. Diplopia is known to occur for optical, neuroophthalmological, strabismological and even iatrogenic reasons following various ophthalmic surgical procedures. The mainstays of the nonsurgical treatment of diplopia including no treatment, partial or total occlusion, press-on or ground in prisms and vergence exercises (to increase fusional vergence amplitudes) have been utilized for some time. Although a review of the literature demonstrates that very little has been published on this topic in recent years, subtle treatment variations have evolved. The ability to successfully manage patients' diplopia symptoms remains important to decrease the risk of patient injuries, as well as maximize their independence and quality of life. These concerns are especially important as patients age.

PurposeTo evaluate 3-year safety and intraocular pressure (IOP) following two trabecular microbypass stents in phakic and pseudophakic subjects with open-angle glaucoma (OAG) not controlled on preoperative medication.Patients and methodsIn this prospective pilot study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 30 mmHg on one preoperative topical ocular hypotensive medication underwent medication washout. Thirty-nine qualified subjects with preoperative unmedicated IOP ≥22 mmHg and ≤38 mmHg received two stents. Postoperative examinations were scheduled at Day 1, Week 1, Months 1, 3, 6, and 12, and semiannually through Month 60. Ocular hypotensive medication was considered if postoperative IOP exceeded 21 mmHg. IOP, medication use, and safety were assessed at each visit. Subject follow-up through Month 36 was completed.ResultsThirty-six eyes (92.3%; 95% confidence interval [CI] 79.1%, 98.4%) achieved the primary efficacy end point of Month 12 reduction in IOP ≥20% from baseline (unmedicated IOP) without ocular hypotensive medication. Four subjects required medication during the Month 36 follow-up period. Mean IOP at 36 months for subjects not taking medication was 15.2 mmHg. At 36 months, subjects sustained mean IOP decrease of 9.1±2.7 mmHg (95% CI 8.0 mmHg, 10.14 mmHg), or 37% IOP reduction, from unmedicated baseline IOP. Compared to preoperative medicated IOP, subjects had mean reduction at Month 36 of 5.5±2.7 mmHg (95% CI 4.5 mmHg, 6.6 mmHg), or 26% reduction. Both measures of IOP reduction were highly significant (P<0.001). Other than one case of early postoperative hyphema that resolved at 1 week, no postoperative adverse events were attributed to stent implantation.ConclusionIn a pilot study, two trabecular microbypass stents to treat OAG subjects on one preoperative medication provided statistically significant, sustained, and safe reduction of IOP to ≤15 mmHg without medication through 36 months.