Elsevier

Ophthalmology

Volume 114, Issue 5, May 2007, Pages 860-865.e1
Ophthalmology

Original Article
The IOL-Vip System: A Double Intraocular Lens Implant for Visual Rehabilitation of Patients with Macular Disease

Presented in part at: Association for Research in Vision and Ophthalmology annual meetings, April 2004 and April 2006 (poster session), Ft. Lauderdale, Florida.
https://doi.org/10.1016/j.ophtha.2007.01.005Get rights and content

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 ×1.3 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 ×6.2, 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.

Section snippets

Materials and Methods

The IOL-Vip System consists of 2 IOLs that reproduce an intraocular Galilean telescope: a high minus-power biconcave IOL (about −66 diopters [D]) in the capsular bag acts as the eyepiece, and a high plus-power biconvex IOL (about +55 D) in the anterior chamber (AC) acts as the objective. Both lenses are made of polymethyl methacrylate, have a 1-piece design, and provide ultraviolet light filtering. The optic of the 2 lenses is 5 mm in diameter, with a maximum axial thickness of 1.5 mm for the

Results

The double IOL surgical procedure was well tolerated in all cases, and the follow-up did not substantially differ from that of normal phacosurgery using a single IOL implant (Fig 2). The same was true for the procedure-related endothelial cell loss of 7% (mean preoperative count, 2716; mean postoperative count, 2513), evaluated in 38 of 40 patients at the end of a mean follow-up of 20 months (range, 7–35). It is worth noting that the patient with the lowest preoperative count, 1783 cells/mm2,

Discussion

There are various hereditary or acquired retinal disorders that give rise to macular degeneration, of which AMD is very frequent and the leading cause of legal blindness in developed countries. However, despite the frequency of these diseases the available treatments cannot prevent severe central vision loss in most cases, and impaired foveal function reduces patients’ ability to carry out everyday activities such as reading, writing, or grooming. Although most patients retain sufficient visual

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Manuscript no. 2005-647.

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