Understanding the New Device to Treat Negative Dysphotopsia: A Study Overview
The article is a synopsis of a prospective interventional study that explored an innovative device designed to be implanted in the eye’s sulcus. The device aims to relieve the symptoms of a condition known as negative dysphotopsia (ND).
The Study’s Design and Execution
The study was carried out in well-established eye centres in India, involving several patients who were experiencing ND. The device, known as the ND ring implant, has a unique design. It’s made from a special hybrid hydrophilic acrylic and has a diameter of 12.8 mm with a 5-mm inner diameter. The device is 0.25 mm thick and its bi-concave cross-section channels light to the area affected by the ND shadow.
The device is inserted into the anterior chamber of the eye through a small 2.2-mm incision, using a single-use injector and cartridge that comes with it. Among the 38 patients with ND who were part of the study, 15 chose to have the ND ring implanted in the eye affected by ND, forming the treatment group. Seven patients chose to have the ring implanted in their other eye during cataract surgery, forming the prophylactic group. The rest of the patients declined the ring implant.
The Results of the Study
The study showed promising results. A staggering 93% of the treatment group reported a total resolution of their ND symptoms. Additionally, none of the prophylactic group reported experiencing ND in the eye in which the ring was implanted. The study also revealed that the device did not cause significant anterior segment inflammation, and no iris rubbing, chafing, or transillumination defects were observed until the one-year follow-up examination. Importantly, there were no notable changes in refraction in either group.
The Study’s Limitations
Despite the positive outcomes, the study had its limitations. For instance, it lacked a quantitative assessment of ND. Moreover, the study’s sample size was somewhat small. The study also did not discuss changes over time in pupil size, capsule fibrosis, and capsulorrhexis.
The Clinical Impact of the Study
The study’s findings could prove invaluable. The device offers a potential solution to a significant and often unpredictable result of cataract surgery. Patients who develop ND often face challenges due to the difficulty and unreliability of resolving the issue. The experimental device has a unique action mechanism that may address the problem of the peripheral retinal shadow between light rays refracted by the nasal IOL optic and those that miss the optic. This means it could sidestep the need for more complex IOL exchange techniques that require advanced surgical skill. However, further evaluation will be required before the ND ring can be submitted for approval by regulatory bodies.
Dr. Amal Alwreikat, who was part of the study, reported no financial relationships. The findings of this study were published in the Journal of Cataract & Refractive Surgery in February 2024.
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