Take-Home Message: The Telescopic Intra-Ocular Lens for Visually Impaired People Revolution system is promising to improve the vision in patients with maculopathies.
By Lynda Charters; Reviewed by Fabio Patelli, MD
The Telescopic Intra-Ocular Lens for Visually Impaired People (IOL-VIP) Revolution System (iolAMD) shows promise for patients with retinal diseases. Its use can provide at least twice the best-corrected visual level (BCVA) that the patients had at baseline, as well as improve their quality of life.
“Age-related macular degeneration (AMD) and other retinal diseases, such as Stargardt’s disease and cone dystrophies, affect many people worldwide by reducing their levels of visual acuity (VA),” Fabio Patelli, MD, said. “Numerous visual aids–ranging from magnifiers, extra-strong glasses, telescopic glasses, and other electronic devices–are available to help these patients. Surgical approaches, such as macular translocation and choroidal grafts, have had less than satisfactory results.”
However, the intraocular telescope might offer higher levels of vision than those obtained in this low-vision patient population. “The intraocular telescope is a technology that retinal surgeons might not have considered,” he added.
Dr. Patelli is a vitreoretinal surgeon, director of vitreoretinal service, ASST Santi Paolo e Carlo Hospital, University of Milan, Italy.
The IOL-VIP Revolution System is one of four intraocular telescopes that have been devised. “This double IOL implant has a prismatic effect with a magnification rate of 1.3 times for distance,” Dr. Patelli said.
The system, with its two rigid polymethylmethacrylate IOLs, reproduces an intraocular Galilean telescope. The two lenses–one biconcave IOL with asymmetric loops and a high minus power and the other, a biconvex IOL with a high plus power–are implanted in the capsular bag to create a prismatic effect because they are misaligned, Dr. Patelli explained.
The interaction of the two IOLs deviates the image to the preferred retinal locus that is predicted before implantation of the device.
The surgery itself is easy to perform. After cataract surgery, a ring is implanted that contains the IOL haptics of the two IOLs. The first IOL is implanted and rotated in the capsular bag.
The second IOL is implanted with axes perpendicular the first IOL. The most important aspect is positioning the haptics of the second IOL. The optics of both IOLs are in the capsular bag.
“The advantages of the technique are the eye movement control with the field of view, a stable increase of the VA both for distance and near vision as a result of the magnification, deviation of the images to the preferred retinal locus as a result of the 10 D prismatic effect, and a binocular view,” Dr. Patelli said.
The most difficult aspect of this technology is patient selection, Dr. Patelli pointed out. The candidate criteria included phakic patients, the presence of a maculopathy, a decimal BCVA less than 0.3 decimal, preserved visual field, ability to follow a rehabilitation program postoperatively, and an improvement in the BCVA seen during the preoperative simulation test.
“This last factor is important because of the ability to predict the outcome after surgery using the simulation test preoperatively,” Dr. Patelli emphasized.
The study had 2 patient groups: group 1 in which the patients had a decimal BCVA less than 0.1 decimal using electronic video devices (CCTVs) for reading and group 2 in which the patients with a decimal BCVA better than 0.1 decimal used optical magnifiers for reading.
The patients were evaluated at 1, 3, and 6 months postoperatively. The primary outcome was a gain in the BCVA at the end of the follow-up period. The secondary outcome was evaluation of the use of the visual system in group 1 and the reading distance in group 2 at the end of the follow-up period.
The IOL system has been implanted in 81 eyes over the previous 10 years. All patients were followed for at least 1 year.
Of these patients, 70 had AMD, 4 had Stargardt’s disease and myopic maculopathy, and 3 had cone dystrophy. One intraoperative complication, capsular bag rupture, occurred in 1 patient and prevented implantation of the system. Postoperatively, 40% of patients reported halos that were not visually relevant.
Dr. Patelli reported that group 1 included 58 eyes and group 2 had 23 eyes. The total mean preoperative BCVA was 0.067 decimal and at the 6-month evaluation it was 0.181 decimal, a difference that reached significance (p < 0.001).
Of the 58 eyes in group 1, 56 (96.5%) eyes achieved a final decimal BCVA better than 0.1 decimal. These patients were able to read using optical magnifiers instead of electronic CCTVs.
In group 2, the mean reading distance improved from 10.14 cm preoperatively to 21.93 cm at the final follow-up visit, which increased patient comfort while reading. In the patients with AMD, postoperatively the VA level was at least double that of preoperatively.
The next step in testing this technology involves use of foldable IOLs, which Dr. Patelli said will be much easier to implant. The investigators are planning to enroll 64 phakic patients with dry AMD.
The study will include 2 groups: 1 with IOL-VIP implantation and the other with normal monofocal IOL implantation. The VAs of the 2 groups will be compared postoperatively. Patients will be followed for 2 years.
“The IOL-VIP Revolution system is safe and well tolerated by the patients,” Dr. Patelli concluded. “The surgery is not difficult to perform and is associated with a short learning curve.
“The BCVA results are equal to or better than the predicted BCVA simulation test, which improves their quality of life,” he added. “The reduction of the visual field is minimal, between 7% to 10%, and comfortable for patients. Binocular implantation is possible and well tolerated. In most cases, the patients can use optical magnifiers instead of electronic CCTVs.”
Fabio Patelli, MD
This article was adapted from a presentation that Dr. Patelli delivered at the 2017 American Society of Retina Specialists meeting. Dr. Patelli has no financial interest in this technology.