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

Yuzuncu Yıl University

Status: Enrolling

Conditions: Cataract; Lens Implantation, Intraocular

Treatments: Device: Acriva BB UDM 611

Study type: Interventional

Funder types: Other

Identifiers

NCT06238271

02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

UDM 611

Experimental group

Description:

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

Treatment:

Device: Acriva BB UDM 611