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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238271
• Other study ID #: 02
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Yuzuncu Yil University
• Contact: Erbil Seven, MD, Associate Professor
• Phone: +90 (432) 2150474
• Email: erbilseven[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Cataract
• Lens Implantation, Intraocular

Intervention

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.

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University	Van

Sponsors (2)

Lead Sponsor	Collaborator
Yuzuncu Yil University	VSY Biotechnology

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Monocular best corrected distance visual acuity	12 to 18 months after surgery