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

January 25, 2024 updated by: Erbil Seven, Yuzuncu Yıl University

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

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

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Erbil Seven, MD, Associate Professor
  • Phone Number: +90 (432) 2150474
  • Email: erbilseven@gmail.com

Study Locations

  • Turkey
      • Van, Turkey, 65090
        • Recruiting
        • Van Yüzüncü Yil University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UDM 611
Acriva BB UDM 611 intraocular lens will be implanted into the capsular bag in patients who undergo cataract extraction with phacoemulsification.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 12 to 18 months after surgery
Monocular best corrected distance visual acuity
12 to 18 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Collaborators

VSY Biotechnology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Estimated)

February 2, 2024

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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