Corneal inlay for presbyopia shows promise without added visual problems in pseudophakes

Print 02 July 2015
Lynda Charters; Ralph Chu, MD / Ophthalmology Times

Initial results show good near vision, high patient satisfaction; no dysphotopsia

Bloomington, MN - Initial results with an investigational device for correcting presbyopia (Raindrop Near Vision Inlay, Revision Optics) are promising. The device improves near visual performance without added visual disturbance in pseudophakic patients.

Other options used to correct presbyopia include monovision LASIK, which provides good intermediate vision but patients may have to depend on spectacles for near-vision tasks. Implantation of multifocal IOLs is another option, but vision can be affected by glare and halos in more than 75% of patients.

“The Raindrop Near Vision Inlay improves near vision without dysphotopsia,” said Ralph Chu, MD, private practice in Bloomington, MN.

The device is a microscopic hydrogel inlay, 2 mm in diameter and about 32-μm thick. When the inlay is implanted under a flap, creased with a femtosecond laser, it changes the curvature of the cornea to a prolate shape, according to Dr. Chu.

U.S. IDE study

Dr. Chu evaluated his group of 25 subjects implanted with the device as part of a U.S. IDE study. In a multicenter study, he assessed and compared the initial feasibility of implanting the device in patients who had previously undergone cataract surgery and IOL implantation as part of the Raindrop Near Vision Inlay U.S. study. All patients were either phakic presbyopes (25 patients) or pseudophakic presbyopes (13 patients), the latter of which had a monofocal IOL.

In both groups, the implant was put into the nondominant eye. Dr. Chu measured the near, intermediate, and distance visual acuities. He followed with a patient survey to measure how well patients were able to perform tasks and their levels of satisfaction with the implanted device.

The phakic patients were an average of 49 years of age (range, 46 to 56 years). The preoperative manifest refraction spherical equivalent (MRSE) was 0.30 D (range, –0.25 D to 1.00 D), the preoperative add was 1.71 D (range, 1.50 D to 2.25 D). The patients were followed for 12 months.

The pseudophakic patients were an average age of 65 years (47 to 78 years). The preoperative MRSE was –0.02 D (range, –0.50 D to 0.38 D), and the preoperative add was 2.06 D (1.75 D to 2.50 D). The patients were followed for 3 months.

Dr. Chu reported that in the phakic group, 84% of patients had 20/20 or better uncorrected near visual acuity 3 months postoperatively. By 12 months postoperatively, all patients reached that visual acuity level.

In the pseudophakic group, the results were similar. At 3 months, 83% of patients had 20/20 or better uncorrected near visual acuity.

Measurement of the uncorrected binocular vision at 3 months showed that 95% of the phakic group and 83% of the pseudophakic group achieved 20/20 or better at distance and near.

“There were minimal reports of visual symptoms for both groups at 3 months with a slight increase in ocular dryness in the pseudophakes,” Dr. Chu said.

Some ocular dryness

Eight percent of the pseudophakes reported ocular dryness. In the phakic group, visual glare and halos were reported by 4% each.

In the phakic group, 84% reported little or no difficulty performing near hobbies; 100% of those in the pseudophakic group reported little or no difficulty with near hobbies.

The level of patient satisfaction was high in both groups, i.e., 97% in the phakic group and 100% in the pseudophakic group, Dr. Chu noted.

The inlay improves near vision equally in phakic presbyopes and in pseudophakes, he summarized. The percentages of moderate or worse visual symptoms were low in both groups, with 4% of phakic subjects reporting glare and halos. No pseudophakic subjects reported either glare or haloes postoperatively. The rates of patient satisfaction were high in both groups. The initial results showed that inlay improves near visual performance without added dysphotopsia in pseudophakic patients.

This article was adapted from Dr. Chu’s presentation during the 2015 meeting of the American Society of Cataract and Refractive Surgery. Dr. Chu is a clinical investigator for ReVision Optics.

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