Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes (LARA)

August 25, 2022 updated by: Universitaire Ziekenhuizen KU Leuven
To determine the surgical outcome and patient satisfaction in patients who underwent AT LARA lens implantation during or after vitrectomy at a relatively young age (around 55 years of age), mostly to treat (urgent) retinal detachment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The surgical outcome is defined as the patient satisfaction determined by patient questionnaires.

  • Visual quality: CatQuest questionnaire
  • Near vision: NAVS questionnaire
  • Glare: APPLES questionnaire

These questionnaires are standardized and validated, although no cut-off values have been determined. Hence, the results drawn from these questionnaires are descriptive only.

Study Type

Interventional

Enrollment (Actual)

90

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 Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients that had a LARA IOL implanted in combination with vitrectomy.
  • patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy.

Exclusion Criteria:

  • Patients with a LARA IOL implanted without concomitant or earlier vitrectomy

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1: LARA IOL implanted in combination with vitrectomy.
intraocular lens implantation in combination with vitrectomy
Procedure: intraocular lens implantation
Lens surgery during or before vitrectomy surgery.
Active Comparator: group 2: LARA IOL implanted in during surgery for cataract secondary to vitrectomy
intraocular lens implantation during surgery for cataract secondary to vitrectomy
Procedure: intraocular lens implantation
Lens surgery during or before vitrectomy surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual quality
Time Frame: 2 weeks
Catquest questionnaire measuring activity limitations in daily life due to poor vision
2 weeks
near vision
Time Frame: 2 weeks
Near Activity Visual Questionnaire (NAVQ) evaluating the near vision
2 weeks
glare
Time Frame: 2 weeks
The Assessment of Photic Phenomena and Lens Effects (APPLES) questionnaire assessing the glare
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binocular performance
Time Frame: 2 weeks
visual acuity
2 weeks

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

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)

February 14, 2022

Primary Completion (Actual)

August 17, 2022

Study Completion (Actual)

August 17, 2022

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S65356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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