Purpose: To investigate the efficacy of a new surgical and rehabilitative procedure designed to improve vision in patients with central scotoma due to macular diseases.
Design: Case series of 40 consecutive surgical and rehabilitative procedures.
Participants: Forty eyes of 35 consecutive patients with a stable central scotoma due to macular disease underwent phacoemulsification cataract surgery with the implant of the IOL-Vip System.
Methods: The IOL-Vip System consists of a biconcave high minus-power intraocular lens (IOL) in the capsular bag and a biconvex high plus-power IOL in the anterior chamber, reproducing an intraocular Galilean telescope with x1.3 magnification for distance. Selection of the candidate patients was carried out by means of a low-vision diagnostic and rehabilitative program (IOL-Vip software) that evaluates the residual visual function of patients and prognosis for visual improvement based on simulation of the postoperative condition. The software also designs the rehabilitation strategies based on preoperative and postoperative training of the preferred retinal locus.
Main outcome measures: Best-corrected visual acuity (BCVA), evaluated by means of the Early Treatment Diabetic Retinopathy Study charts and procedure; reading magnification; and reading distance.
Results: All patients showed an improvement of visual acuity (VA) due to the surgical and rehabilitative procedure, confirming or exceeding the preoperative expected results. Mean postoperative BCVA was 0.77 (logarithm of the minimum angle of resolution), compared with 1.28 preoperatively. The mean postoperative best reading magnification gain was x6.2, and the mean postoperative reading distance gain was 7.66 cm. No cases of intraoperative or postoperative complications were detected, and the implant was subjectively well tolerated in both monocular and binocular procedures.
Conclusion: In this pilot study, the IOL-Vip System was shown to be effective and apparently well tolerated in improving the vision of patients with macular disease. Best-corrected VA, reading magnification, and reading distance improved in all cases of this low-vision patient series.