Evaluation of the Long-term Efficacy and Safety of Monofocal Plate Haptic Intraocular Lens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-23

Study Completion Date

2025-05-31

Brief Summary

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Our study aims to determine the efficacy and safety of the monofocal plate haptic intraocular lens to be implanted in patients planning for cataract surgery and to determine the complications that may develop due to the lens.

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Detailed Description

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This study was planned to be performed on 300 eyes with surgical indication due to cataracts in Van Yüzüncü Yıl University Faculty of Medicine Ophthalmology Outpatient Clinic. Uncorrected and best-corrected visual acuity, subjective refraction, slit-light biomicroscopy, optical biometry, anterior segment optical coherence tomography, intraocular pressure, endothelial cell count in the pre-and postoperative (1st, 3rd, and 12th months) controls of the patients. Fundus examination will be performed, and postoperative complications and accompanying ocular pathologies will be recorded. Data before and after surgery effectiveness will be evaluated. Reliability will be interpreted by considering postoperative complications.

Conditions

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Lens Implantation, Intraocular Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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UDM 611

Acriva BB UDM 611 intraocular lens will be implanted into the capsular bag in patients who undergo cataract extraction with phacoemulsification.

Group Type EXPERIMENTAL

Acriva BB UDM 611

Intervention Type DEVICE

Acriva BB UDM 611 intraocular lens will be implanted into the capsular bag in patients who undergo cataract extraction with phacoemulsification.

Interventions

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Acriva BB UDM 611

Acriva BB UDM 611 intraocular lens will be implanted into the capsular bag in patients who undergo cataract extraction with phacoemulsification.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Patients of any gender
* Assured follow-up examinations
* Biometry measurement preferably compatible with the Lenstar evaluation;
* IOL implanted into the capsular bag with IOL model Acriva BB UDM 611 (UVE material) in one or both eyes

Exclusion Criteria

* BCVA not available preoperatively or better than 0.3 logMAR pre-op
* Patients unable to meet the limitations of the protocol or likely to non-cooperation during the trial
* Patients with peroperative complications (Such as capsulorhexis problems that affect centralization, failure of the IOL implanting into the bag, posterior capsular rupture, iris damage, vitreous loss, IOL damage, etc.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No