Trial reportTranslational vision science & technology2026
Safety and Efficacy of a New Endocapsular Device Used in Age-Related Cataract Surgery: Twelve-Month Follow-Up.
Trial report in Translational vision science & technology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Optical Quality and Centration Stability of a Novel Capsule Reconstructor for Intraocular Lens Fixation: Laboratory Evaluation of the fixOflex Device.Translational vision science & technology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: To evaluate the safety and efficacy of a novel endocapsular device used during cataract surgery at the 12-month follow-up. Methods: A cohort study was conducted in a university-affiliated private practice. Adults with age-related cataracts, intraocular lens power between 14 and 26 diopters, and no other ocular pathology were included prospectively. Exclusion criteria included diabetes, previous ocular surgery, cardiac conditions, and autoimmune diseases. One eye per patient was randomly assigned to receive the device before intraocular lens implantation. Follow-ups were conducted preoperatively and at 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. The primary safety endpoint was the incidence of adverse events; the primary efficacy endpoint was the incidence of posterior capsule opacification (PCO) postoperatively at 12 months. A control group was formed retrospectively for comparison of PCO at 12 months. Spherical equivalent, corrected distance visual acuity, and intraocular pressure were also measured. Results: A total of 121 patients were enrolled. Sixteen adverse events occurred in 12 patients; all resolved and were deemed unrelated to the device. PCO incidence at 12 months was 0.83% in the experimental group vs. 13.0% in the control group. The spherical equivalent stabilized by 3 months. At 12 months, the mean corrected distance visual acuity and intraocular pressure were 0.03 ± 0.07 logarithm of the minimum angle of resolution and 11.23 ± 2.03 mm Hg, respectively. Conclusions: The new device seems to be safe and have a beneficial impact on PCO up to at least 12 months postoperatively. Translational Relevance: We report our experience with a novel, safe, endocapsular open capsule device that shows promise in preventing posterior capsule opacification in real-world clinical settings.
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