Visual acuity, visual symptoms are driver for corneal inlay satisfaction

Take-Home

A corneal presbyopia inlay seems to have overcome two obstacles to patient satisfaction by providing good near vision without glare and halos.

Dr. Steinert

By Lynda Charters; Reviewed by Roger F. Steinert, MD

Irvine, CA-Corneal inlays for presbyopia are a treatment modality worthy of consideration, according to Roger Steinert, MD.

The demand for surgical correction of presbyopia has been increasing, and LASIK and multifocal IOLs have provided limited success for patients with presbyopia, explained Dr. Steinert, the Irving H. Leopold Professor and Chair, professor of biomedical dngineering, and director, Gavin Herbert Eye Institute, University of California, Irvine.

One such investigational corneal inlay-which has the same refractive index as the cornea-works by reshaping Bowman’s layer and the anterior cornea to create smooth transition zones for near, intermediate, and distance vision. The hydrogel inlay (Raindrop Near Vision Inlay, ReVision Optics) is a cross-linked methylmethacrylate/vinyl pyrrolidone) copolymer with a high-water content (78%) when fully hydrated.

The device-which currently is implanted monocularly in the United States-is positioned in the cornea at about a depth of 200 µm. The inlay provides plus power with a profocal shape in the corneal center, he explained.

Study of the inlay

Dr. Steinert and his colleagues conducted a multicenter, prospective, non-randomized case series that included 45 patients who underwent implantation of the corneal inlay in the non-dominant eye.

Patients were evaluated preoperatively and at 1, 3, 6, 9, and 12 months postoperatively. Among the main factors measured were uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), patients’ self-reported symptoms, and patients’ satisfaction with near and distance visual acuity and overall.

Investigators performed univariate, multivariate, and longitudinal analyses of the data amassed from study of the corneal implant to determine which factors were associated with patient satisfaction with corneal inlay refractive surgery to correct presbyopia.

Univariate and multivariate analyses showed that visual acuity and visual symptoms are the main drivers of patient satisfaction, according to Dr. Steinert.

For example, glare and halos are associated with multifocal IOL implantation, and visual dysphotopsias cause the greatest dissatisfaction. The presence of glare and halos seem to have a greater impact on patients’ perceptions of visual outcomes than the visual acuity at any distance.

Patients who expressed satisfaction with the corneal inlay were found to have a mean UNVA at all postoperative evaluations that was almost 20/20. Patients who expressed dissatisfaction had a postoperative UNVA of about 20/25 to about 20/30.

The data showed a smaller difference in the UDVA (about 20/32) between patients who were satisfied and those who were not.

“Better near acuity in the eye with the inlay was associated with higher near and overall patient satisfaction,” Dr. Steinert said. “Better distance acuity in the eye with the inlay was not associated with greater distance vision or overall patient satisfaction.”

Patient satisfaction

Patients graded their symptoms-which included glare, halos, visual fluctuations, and diplopia-on a scale of 0 to 4, with 0 indicating no symptoms and 4 indicating severe symptoms. The maximal possible score was 16.

When the cumulative intensity score was evaluated regarding distance vision, most patients who were satisfied with near vision had a cumulative intensity symptom score that was near the preoperative score. The cumulative intensity score of the unsatisfied patients peaked at 1 month postoperatively at about 5 and by month 12 was 2.

Stronger visual symptoms were associated with lower odds of near, distance, and overall patient satisfaction, Dr. Steinert noted.

“The big drivers of patient satisfaction are uncorrected near vision and the lack of symptoms, especially halos and glare,” he said. “Interestingly, the mild reduction in distance vision was the least important issue related to patient satisfaction with the procedure.

“This runs counter to concerns that people have had regarding corneal inlays and shows that if patients achieve good reading vision without glare and halos-which [this corneal inlay] seems to accomplish in well over 90% of patients-they are very happy with the procedure,” Dr. Steinert concluded.

Roger F. Steinert, MD

E: steinert@uci.edu

Dr. Steinert is a consultant and medical monitor for ReVision Optics.

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