NCT04397068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

March 14, 2016

Last Update Submit

May 16, 2020

Conditions

Macular Pucker

Outcome Measures

Primary Outcomes (1)

  • Compare if ELP is different or the same at phaco or phaco-vitrectomy

    Anterior chamber depth measured using IOL master.

    6 - 8 weeks

Study Arms (1)

macular pucker wherefore vitrectomy

OTHER

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

Procedure: phaco-vitrectomy

Interventions

phaco-vitrectomyPROCEDURE

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

macular pucker wherefore vitrectomy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Peter Stalmans

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd, MD

Study Record Dates

First Submitted

March 14, 2016

First Posted

May 21, 2020

Study Start

March 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)