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Physicians share clinical experience with near vision inlay in pseudophakic patients
Patients who received the Raindrop inlay had a significant improvement in near and intermediate visual outcomes.
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Pseudophakic patients with presbyopia who want to be spectacle- or contact lens-free after cataract surgery often turn to LASIK treatment. However, there is growing evidence to suggest that corneal inlays can help improve near and intermediate vision in pseudophakic patients implanted with a monofocal IOL.
Outcomes in pseudophakic patients
Several corneal inlays are available on the European, Asian and South American market, including the Raindrop near vision inlay (ReVision Optics). We recently evaluated the efficacy of the Raindrop in a cohort of pseudophakic patients with presbyopia. In this study, we implanted the Raindrop in the nondominant eye of 27 pseudophakic patients (mean age: 51 years; range: 27 to 77 years) who had been previously implanted with a monofocal IOL; 14 patients were also treated with concurrent LASIK, of whom seven received bilateral LASIK. Preoperatively, the mean manifest refraction spherical error was 0.09 D (range: –1.12 D to 1 D), and the mean add was +2.44 D (range: 2 D to 2.5 D). Outcomes were assessed at 1 day, 1 week, 1 month, 3 months and 6 months postoperative.
At the 6-month follow-up, patients had improved by an average of four lines in uncorrected near visual acuity in the treated eye. Binocularly, all but one subject had 20/32 or better uncorrected near visual acuity. Patients also gained two lines in uncorrected intermediate visual acuity in the Raindrop-implanted eye, and 88% achieved 20/25 vision or better binocularly. Typically, near vision inlays compromise the patient’s distance vision, although we found that there was no loss in uncorrected distance visual acuity, and binocularly, all but one patient had 20/25 vision or better at the 6-month follow-up visit.
An evaluation of side effects and symptoms after Raindrop implantation revealed that occurrences of glare, dryness, halos and fluctuations were either mild or nonexistent, although one patient reported “moderate” dryness in the treated eye. There were also three cases of trace haze at 6 months postoperative. The majority of patients stated that they were either satisfied or very satisfied with their overall visual outcomes. One patient reported dissatisfaction, but this was only with near vision.
Overall, visual and safety outcomes in our cohort of pseudophakic patients were positive and echoed or improved upon those described in a 20-eye study undertaken in emmetropes. Data from the study, undertaken by Garza and colleagues, showed that of the 19 eyes available for examination at 12 months, 100% achieved an uncorrected near visual acuity of 0.2 logMAR (20/32 Snellen) or better in the Raindrop eye. Binocularly, 100% of patients achieved an uncorrected near visual acuity of 0.18 logMAR (20/31 Snellen) or better. All patients maintained binocular distance vision from 3 months postoperatively onward, and no eye lost two or more lines of corrected distance visual acuity or corrected near visual acuity.
Of note, we found that visual outcomes after implantation with the Raindrop remained stable through the 6-month follow-up period.
Considerations
The Raindrop has some limitations. For example, it is unsuitable for patients with dry eye disease, meibomian gland dysfunction, a history of chronic ophthalmic allergies or any form of corneal pathology. It is also contraindicated in patients with conditions that may affect wound healing. Patients must have a central corneal thickness of more than 480 µm in order to implant the inlay under a femtosecond flap one-third the central corneal thickness while maintaining a 300 µm stromal bed.
These limitations notwithstanding, the Raindrop led to a significant improvement in near and intermediate visual outcomes in our cohort of pseudophakic patients. Data from our study indicate that cataract patients with presbyopia now have a safe, minimally invasive treatment option to improve their near and intermediate vision.
Disclosures: Yen and Tran report they are clinical investigators and consultants for ReVision Optics.