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

Primary Purpose

Macular Pucker

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
phaco-vitrectomy
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Pucker

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitaire Ziekenhuizen Leuven

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

macular pucker wherefore vitrectomy

Arm Description

one eye phaco-vitrectomy and other eye only phaco. No other involvement of drug or device. Standard of care procedure

Outcomes

Primary Outcome Measures

Compare if ELP is different or the same at phaco or phaco-vitrectomy
Anterior chamber depth measured using IOL master.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2016
Last Updated
May 16, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04397068
Brief Title
Compare ELP in Patients With Elective Phaco-VTX Surgery in One Eye and a Single Lens Phaco Surgery on the Other Eye
Acronym
ELP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Pucker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
macular pucker wherefore vitrectomy
Arm Type
Other
Arm Description
one eye phaco-vitrectomy and other eye only phaco. No other involvement of drug or device. Standard of care procedure
Intervention Type
Procedure
Intervention Name(s)
phaco-vitrectomy
Intervention Description
phaco-vitrectomy. No other involvement drug or device. Standard of care procedure
Primary Outcome Measure Information:
Title
Compare if ELP is different or the same at phaco or phaco-vitrectomy
Description
Anterior chamber depth measured using IOL master.
Time Frame
6 - 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Stalmans
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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