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

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Description

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.

Study Overview

Start Date
November 23, 2022
Completion Date
May 1, 2025
Enrollment
300
Date Posted
February 2, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Van Yuzuncu Yil University
Van 65090, Turkey

Eligibility

Minimum Age (years)
18
Eligibility Criteria
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.)

Study Contact Info

Study Contact Name
Erbil Seven, MD, Associate Professor
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
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.
NCTid (if applicable)
NCT06238271