Hydrogel corneal inlay studied as 'valuable' tool for presbyopic

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Outcomes from up to 12 months of follow-up in a prospective case series including 25 patients show promising results using the transparent, hydrogel corneal inlay for correction of presbyopia.

By Cheryl Guttman Krader; Reviewed by Julian Theng, MD

Singapore-Early outcomes with a transparent, hydrogel corneal inlay (Raindrop, ReVision Optics) support its role as an option for correcting presbyopia, according to Julian Theng, MD.

“The inlay delivered very consistent near improvement to N5 or better along with improved intermediate visual acuity,” said Dr. Theng, chairman and founder, Eagle Eye Centre, Singapore. “There were no significant complications, and patient satisfaction was very high. The surgery involves a learning curve, but the procedure is quick, easy, and reversible.

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“Based on this early assessment, I consider the hydrogel corneal inlay a valuable tool in my surgical armamentarium for correcting presbyopia,” said Dr. Theng, who reported favorable experience in his first 25 patients who received the device at the center.

The inlay is made of a transparent biocompatible material with properties mimicking a healthy cornea. The device is implanted in the non-dominant eye under a 150-µm corneal flap, creating a smooth focal gradient in the center of the cornea to improve near and intermediate vision.

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Findings from series

Of the 25 patients in Dr. Theng’s series, five patients with low hyperopia preoperatively (mean MRSE +0.62 D, range +0.5 to +0.75 D) received the inlay only. The other 20 patients whose preoperative MRSE ranged from –1.25 to +1.75 D preoperatively (with up to –1 D of cylinder) underwent concurrent LASIK with a target refraction of +0.75 D.

The patients are being followed quarterly. Twenty-one patients were seen at 1 and 3 months, 17 patients were evaluated at 6 months, but only six patients have reached the 1-year visit.

Mean monocular near uncorrected visual acuity (UCVA) in the inlay eye measured at 30, 40, and 50 cm was N10 preoperatively, improved to almost N5 by 1 month for all near distances, and was stable thereafter. For the patients seen at 6 months, near UCVA at 30 cm was N6 or better in 94% of inlay eyes, and among the patients seen at 12 months, 100% saw N5 or better at 30 cm with their inlay eye.

Monocular distance UCVA in the inlay eye was reduced initially, but improved by 1 week and stabilized by 3 months at a level slightly below baseline.

“Most patients are not disturbed by the slight reduction in distance visual acuity, which ranges from 6/6 to 6/12 vision,” he said. “What is more striking is that they hardly complain of halos and glares.”

Patient satisfaction was very high. Among the 21 patients seen at 1 month, 88% were satisfied and only 6% were dissatisfied. All 6 patients seen at 12 months were satisfied or very satisfied, and all inlays were clear.

Dr. Theng reported that two inlays were exchanged during the surgery-one was damaged and the other was wrinkled. In addition, one inlay was decentered at 1 week and removed.

“The learning curve for the procedure mostly involves learning to handle the inlay gently to avoid damage and positioning it right over the center of the miotic pupil in order to achieve predictably good results,” Dr. Theng said.

Julian Theng, MD

E: juliantheng@eagleeyecentre.com

This article was adapted from Dr. Theng’s presentation at the 2014 meeting of the American Society of Cataract and Refractive Surgery. Dr. Theng received a fee and expenses from ReVision Optics. The near vision inlay is an investigational device.