Clincosm LogoSign in Get a demo

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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04397068
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
13
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: phaco-vitrectomy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Mar 31, 2017
Actual Study Completion Date :
Mar 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Compare if ELP is different or the same at phaco or phaco-vitrectomy [6 - 8 weeks]

    Anterior chamber depth measured using IOL master.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitaire Ziekenhuizen Leuven Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

  • Principal Investigator: Peter Stalmans, Universitaire Ziekenhuizen Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Peter Stalmans, Phd, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04397068
Other Study ID Numbers:
  • S58904
First Posted:
May 21, 2020
Last Update Posted:
May 21, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Epiretinal Membrane

Study Results

No Results Posted as of May 21, 2020