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

Not Applicable

Recruiting

• Conditions: Cataract; Lens Implantation, Intraocular
• Interventions: Device: Acriva BB UDM 611

• Registration Number: NCT06238271
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2022-11-23
• Status Verified: 2024-01
• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-11
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UDM 611	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.

Primary Outcome Measures

Name	Time	Method
Visual acuity	12 to 18 months after surgery	Monocular best corrected distance visual acuity

Trial Locations

Locations (1)

Van Yuzuncu Yil University; 🇹🇷 Van, Turkey