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

Not Applicable

Completed

• Conditions: Macular Pucker
• Interventions: Procedure: phaco-vitrectomy

• Registration Number: NCT04397068
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-14
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-16
• Last Update Submitted: 2020-05-16
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
macular pucker wherefore vitrectomy	phaco-vitrectomy	one eye phaco-vitrectomy and other eye only phaco. No other involvement of drug or device. Standard of care procedure

Primary Outcome Measures

Name	Time	Method
Compare if ELP is different or the same at phaco or phaco-vitrectomy	6 - 8 weeks	Anterior chamber depth measured using IOL master.

Trial Locations

Locations (1)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium