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

NCT ID: NCT04397068

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2017-03-31

Brief Summary

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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

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* 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.

Conditions

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Macular Pucker

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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macular pucker wherefore vitrectomy

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

Group Type OTHER

phaco-vitrectomy

Intervention Type PROCEDURE

phaco-vitrectomy. No other involvement drug or device. Standard of care procedure

Interventions

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phaco-vitrectomy

phaco-vitrectomy. No other involvement drug or device. Standard of care procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Peter Stalmans

Phd, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Stalmans

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S58904

Identifier Type: -

Identifier Source: org_study_id

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