Nancy A. Melville

April 29, 2014

BOSTON — The investigational Raindrop transparent hydrogel corneal inlay (ReVision Optics) is consistently effective in the correction of presbyopia, relatively easy to implant, and has high patient satisfaction, according to several reports on the product.

"I think this technology is going to represent a true paradigm shift in the way we treat our presbyopic patients in the future," said Jeffrey Whitman, MD, from the Key-Whitman Eye Center in Dallas. He is one of several investigators participating in an ongoing multicenter phase 3 US Food and Drug Administration (FDA) Investigational Device Exemption study of the implant.

The transparent inlay is 2 mm in diameter and about 30 µm thick. It is biocompatible and has a water content similar to that of the cornea and the same refractive index. It is designed to be placed on the stroma beneath a 150 µm femtosecond laser-created flap.

There were 3 presentations on the technology here at the American Society of Cataract and Refractive Surgery 2014 Symposium.

The first was by Julian Theng, MD, medical director of the Eagle Eye Centre in Singapore. He reported his experience with 25 patients (54% male). Mean age was 51 years.

The 5 patients who received only the inlay had a mean manifest refraction spherical equivalent of +0.62 diopters. The 20 patients who received the inlay and underwent concurrent LASIK surgery had a mean sphere of –0.05 diopters (range, –1.25 to +1.75) and a mean cylinder of –0.28 diopters (range, 0 to –1.0).

Early results showed depth of near vision improving and stabilizing at 1 month. At 6 months, data on 17 patients showed that 94% had a monocular uncorrected near visual acuity of N6 or better in the inlay eye.

Follow-up data on 21 patients showed improvement in patient satisfaction over time. At 1 month, 88% were satisfied, 6% were neutral, and 6% were dissatisfied.

Data on 6 patients at 12 months showed 100% satisfaction with the procedure, and all corneas in inlay eyes were clear.

"Implantation of the inlay, including centration, is simple, but there is a learning curve," Dr. Theng told Medscape Medical News. "Although the procedure looks very simple and can be done in 5 minutes, surgeons will need to learn to handle the tiny inlay gently and position it right over the center of the pupil for good, consistent results," he said.

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Video provided by Julian Theng, MD, medical director of the Eagle Eye Centre in Singapore. "The procedure is very simple and much like performing LASIK," says Dr. Theng. "You create a 150 µm femtosecond laser flap and lift it. You want to try to have a dry field. You place the inlay onto the stroma over the center of the cornea. It creates a central protrusion improving near and distance vision. The procedure is done quickly, in about 5 minutes."

A Laser Flap Thickness of 150 µm

Another cohort of 17 patients who received the Raindrop inlay was described by Cornelis Verdoorn, MD, from Lasikcentrum in Boxtel, the Netherlands.

The mean age of the cohort was 54 years, and 65% was female. Seven of the patients, with a mean preoperative refraction of +0.25 diopters, received the inlay only. Ten of the patients, with a mean preoperative refraction of +1.73 diopters, received the monocular inlay and underwent concurrent binocular LASIK surgery. The target refraction in the inlay eye was +0.50 to +1.00 diopters.

The inlay patients were compared with 11 patients who underwent monovision LASIK surgery. In that cohort, mean age was 55 years, 73% was female, mean preoperative refraction was +1.31 diopters, and target monovision was –1.50 diopters and –0.75 diopters.

At 3-month follow-up, more patients in the inlay group than in the monovision LASIK group achieved an uncorrected distance visual acuity in the treated eye of 0.4 or better (100% vs 55%). "None of the monovision patients could see 0.8 or better," said Dr. Verdoorn.

In addition, more patients in the inlay group than in the monovision LASIK group had improved near acuity at smaller font sizes, and could read J2 or better (65% vs 36%).

"The Raindrop inlay provided better near vision and more balanced distance vision" than monovision LASIK, reported Dr. Verdoorn.

"I have to stress that the laser flap has to be 150 µm," he added. "If you don't have that thickness, you could have problems, even corneal melting."

Night Driving "Not an Issue"

Dr. Whitman described the mechanism of action of the Raindrop inlay as an epithelial remodeling of tissue over the inlay that establishes a profocal cornea with near vision centered over the pupil.

"There is a gradual transition to intermediate and distance vision out of the periphery, but you don't get contrast or halo issues. Profocal is just a better mechanism of action," he said.

He reported his experience with 82 emmetrope patients; 12-month follow-up was available for 45 of them.

Mean age was 50 years and mean manifest refraction spherical equivalent was +0.30 diopters. At 12 months, uncorrected near visual acuity in the inlay eye was 20/20 or better in 93% of patients, and was 20/25 or better in 82%.

For binocularity at 12 months, 80% of patients achieved a visual acuity of 20/20 or better at all distances, and 100% achieved 20/25 or better.

Dr. Whitman said the inlay is associated with good function in low light conditions. "Driving at night is not an issue," he explained. "Night driving scores are similar to preoperative values at 1 year."

An important feature of the implant is that it is removable. One patient had the implant removed because of recurrent haze, but a longer steroid time, which is part of the FDA protocol, has "virtually eliminated the haze problem," said Dr. Whitman.

Another patient had an explant because of cataract formation.

Moderator Paul Dougherty, MD, who is also participating in the FDA study, said his own experience with the inlay has shown equally impressive results, including with night vision.

"Night driving before and after surgery is essentially identical, and patient satisfaction is extremely high," said Dr. Dougherty, who is medical director of Dougherty Laser Vision in Westlake Village, California, and assistant professor of ophthalmology at UCLA.

Dr. Dougherty noted that, in general, the adverse effects are similar to those with LASIK. In 2 of the 46 eyes he has treated, the implant moved — one because of frequent eye-rubbing and the other because the patient didn't wear their eye shield at night.

He reported that 1 patient asked for the lens to be removed after complaining about distance vision, but subsequently asked for it to be replaced.

Otherwise, he said, patient satisfaction with the inlay has been exceptional.

"This is a phenomenal technology that really helps our patients and has a high rate of satisfaction," Dr. Dougherty told Medscape Medical News. "I think it's going to be a true game-changer in the treatment of presbyopia."

"It is amazing to see how happy these patients are with so few symptoms. It's a very exciting technology," he said.

Dr. Theng reports receiving travel expenses for his presentation from ReVision Optics, but has no other financial relationship with the company. Dr. Whitman and Dr. Dougherty are investigators and consultants for ReVision Optics.

American Society of Cataract and Refractive Surgery (ASCRS) 2014 Symposium. Presented April 25, 2014.

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