Evidence map›Paper›PMID 41649457›Full record

Trial reportTranslational vision science & technology2026

Safety and Efficacy of a New Endocapsular Device Used in Age-Related Cataract Surgery: Twelve-Month Follow-Up.

Ioannis G Pallikaris, Ahmed Elmassry, Harilaos S Ginis, Loukia L Leonidou, Onurcan Sahin, Manolis Modatsos, Dimitris Liakopoulos, Shaimaa Elbassiouny, Aristofanis Pallikaris

Abstract readRandomized Controlled Trial
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ioannis G PallikarisLaboratory of Optics and Vision, Medical School, University of Crete, Heraklion, Greece.
Ahmed ElmassryOphthalmology Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Harilaos S GinisLaboratory of Optics and Vision, Medical School, University of Crete, Heraklion, Greece.
Loukia L LeonidouLaboratory of Optics and Vision, Medical School, University of Crete, Heraklion, Greece.
Onurcan SahinDepartment of Mechatronics, Yıldız Technical University, Istanbul, Turkey.
Manolis ModatsosLaboratory of Optics and Vision, Medical School, University of Crete, Heraklion, Greece.
Dimitris LiakopoulosLaboratory of Optics and Vision, Medical School, University of Crete, Heraklion, Greece.
Shaimaa ElbassiounyEl-Nour Eye Center, Alexandria, Egypt.
Aristofanis PallikarisLaboratory of Optics and Vision, Medical School, University of Crete, Heraklion, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

CataractCataract ExtractionLens Implantation, IntraocularAgedAged, 80 and overCapsule OpacificationFemaleFollow-Up StudiesHumansIntraocular PressureMaleMiddle AgedPostoperative ComplicationsProspective StudiesRetrospective StudiesTreatment Outcome

Identifiers

PMID41649457
PMCPMC12889166

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.