Pinhole sulcus implant for the treatment of irregular corneal astigmatism: 2 year follow-up

Session Details

Session Title: Cataract Surgery Special Cases

Session Date/Time: Monday 09/10/2017 | 14:30-16:00

Paper Time: 15:12

Venue: Meeting Center Room I

First Author: : C.Trindade BRAZIL

Co Author(s): :    B. Trindade   F. Trindade   R. Osher   L. Werner   M. Santhiago        

Abstract Details

Purpose:

The purpose of this article is to present a series of 18 cases of irregular corneal astigmatism, treated with a new pinhole intraocular implant, with a mean follow-up of 22 months. The device, which received a CE Mark in 2016, is intended for sulcus fixation in pseudophakic eyes, in a piggyback configuration.

Setting:

University of Sao Paulo

Methods:

This study was designed as a 2-year prospective non-randomized noncomparative case series to evaluate the impact of a new pinhole sulcus implant in visual acuity of patients with irregular corneal astigmatism. The study was performed at the University of São Paulo, Brazil, in accordance with the Declaration of Helsinki and approved by the Ethics Committee, University of São Paulo. Primary outcome parameters were manifest refraction, visual acuity, subjective patient satisfaction and intraoperative and postoperative adverse events and complications. Also, a subjetive test was performed to evaluate the induction of Pulfrich effect by pinhole implantation.

Results:

BCDVA improved significantly, with preoperative median being LogMAR 0.78 (20/120) ± 0.172 and postoperative LogMAR 0.30 (20/40) ± 0.027 (p=0.002), remaining stable until the last follow-up visit. UNVA improved significantly with preoperative median being LogMAR 0.70 (20/100) ± 0.172 and postoperative LogMAR 0.18 (20/30) ± 0.027 (p=0.002), remaining stable until the last follow-up visit. During the 24-month follow-up period, no implant had to explanted. Intraocular inflammation was limited to the first few post-operative days, and controlled with routine anti-inflammatory regimen. Intraocular pressure remained in the normal range in every patient.

Conclusions:

This novel intraocular pinhole implant is a new alternative for the treatment of irregular corneal astigmatism. In this study, the device performed well in patients with corneal irregularities, with high patient satisfaction. A longer follow-up is necessary to evaluate long term performance.

Financial Disclosure:

gains financially from product or procedure presented