NCT06238271

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

Evaluation of the Long-term Efficacy and Safety of Monofocal Plate Haptic Intraocular Lens to be Implanted Into the Eye in Patients Undergoing Cataract Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Yuzuncu Yil University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lens Implantation, Intraocular
• Cataract

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-11-23
• Primary completion: 2024-11-01
• Completion: 2025-05-01
• First posted: 2024-02-02
• Last updated: 2024-02-02

Locations

1 site across 1 country: Turkey (Türkiye)