Compare ELP in Patients With Elective Phaco-VTX Surgery in One Eye and a Single Lens Phaco Surgery on the Other Eye (ELP)

May 16, 2020 updated by: Prof. Dr. Peter Stalmans, Universitaire Ziekenhuizen KU Leuven

Vergelijking Van de Postoperatieve Effectieve Lenspositie (ELP) Bij patiënten Gepland Voor Een Electieve Phacovitrectomie-ingreep (Phaco-VTX) Aan één Oog en Enkel Een Lensingreep Phaco Aan Het Andere Oog

The aim of the study is to gain more insight into the potential impact of a vitrectomy (removal of the vitreous) on postoperative effective position of the intraocular lens (IOL). Moreover, this study can provide very useful information for the optimal lens calculation in patients undergoing lens extraction with IOL implantation (whether or not combined with a vitrectomy) should undergo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Comparison ELP post phaco VTX (pucker / floaters) versus post phaco and use this information to develop a customized IOL calculation for eyes undergoing phacoVTX.
  • Evidence for recording lens thickness (LT) parameter in the IOL strength calculation in KWS (in the calculation of the ELP in the light of the Olsen formula, using the C-constant) in order to be able to make an even more accurate prediction of the post-operative diopter target of the patient.

Study Type

Interventional

Enrollment (Actual)

20

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
        • Universitaire Ziekenhuizen 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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > 50 yrs
  • macular pucker wherefore vitrectomy is necessary

Exclusion Criteria:

  • macular pathology other than macular pucker
  • Corneal pathology
  • Other ocular pathology that could affect the biometrics or ELP
  • Previous vitrectomy in one of the eyes

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: macular pucker wherefore vitrectomy
one eye phaco-vitrectomy and other eye only phaco. No other involvement of drug or device. Standard of care procedure
Procedure: phaco-vitrectomy
phaco-vitrectomy. No other involvement drug or device. Standard of care procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare if ELP is different or the same at phaco or phaco-vitrectomy
Time Frame: 6 - 8 weeks
Anterior chamber depth measured using IOL master.
6 - 8 weeks

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Peter Stalmans, 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)

March 1, 2016

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

May 16, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 16, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S58904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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