Assesment of Intermediate Vision After BIL Cataract Surgery

April 9, 2024 updated by: Universitair Ziekenhuis Brussel

Assesment of Intermediate and Near Vision After Bag in the Lens Cataract Surgery

The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".

The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.

Participants will:

  • Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)
  • Have to fill in 2 questionnaires about visual functioning and spectacle independance

Researchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

38

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

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent bilateral bag in the lens cataract surgery in the University Hospital Brussels at least 3 months before inclusion

Description

Inclusion Criteria:

  • Patients of at least 18 years old
  • Must have underwent bilateral bag in the lens cataract surgery in the University hospital Brussels at least 3 months before inclusion
  • Must not meet any exclusion criteria

Exclusion Criteria:

  • Prior refractive surgery (other than bag in the lens)
  • Glaucoma
  • Corneal opacities
  • Moderate non proliferative diabetic retinopathy or worse
  • Optic neuropathy
  • History of uveitis
  • Amblyopia
  • Residual post-operative astigmatism higher than 1.5 Diopters (D)
  • Best corrected visual acuity < 1.0
  • Patients unable to cooperate or sign the informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bag in the lens
Patients who underwent bag in the lens cataract surgery at least 3 months before inclusion in the University Hospital Brussels, Belgium.
Procedure: Bag in the lens cataract surgery
Cataract surgery using the Morcher 89A intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intermediate vision
Time Frame: During the only hospital visit required in the study, between april and december 2024
uncorrected and distance corrected intermediate vision at 66cm in LogMAR
During the only hospital visit required in the study, between april and december 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Near vision
Time Frame: During the only hospital visit required in the study, between april and december 2024
uncorrected and distance corrected intermediate vision at 40cm in LogMAR
During the only hospital visit required in the study, between april and december 2024

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Jorgos Koulalis, M.D., Universitair Ziekenhuis Brussel

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24103_BIL_EDOF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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