Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

NCT ID: NCT03927430

Last Updated: 2019-05-01

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

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-03-01

Brief Summary

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Surgical outcome of patients with macular drusen and co-existing abnormalities of the vitreoretinal interface, who routinely undergo pars plana vitrectomy with membrane peeling, is evaluated. Best corrected visual acuity as well as optical coherence tomography data are compared at baseline and last follow up. The rate of development of choroidal neovascularization postoperatively is noted.

Detailed Description

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Conditions

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Epiretinal Membrane Macular Holes Age Related Macular Degeneration

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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pars plana vitrectomy with membrane peeling

23-gauge pars plana vitrectomy with peeling of the epiretinal and internal limiting membrane as well as air- or gastamponade

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. participants diagnosed with ERM or FTMH and co-existing macular drusen;
2. undergone pars plana vitrectomy with ILM and epiretinale membrane peeling;
3. SD-OCT at the initial visit and at last follow up visit with image quality score \>30;
4. no evidence of CNV on initial fluorescein angiography (FA).

Exclusion Criteria

1. history of other macular disease, severe non-proliferative or proliferative diabetic retinopathy, other retinal vascular diseases, glaucoma, myopic retinopathy, or other diseases interfering with OCT images in any one of the eyes;
2. active CNV or history of CNV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinikum Chemnitz gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Katrin Engelmann

Head of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katrin Engelmann, PhD

Role: STUDY_CHAIR

Klinikum Chemnitz

Locations

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Klinikum Chemnitz, Ophthalmology Department

Chemnitz, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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SKC01/2019

Identifier Type: -

Identifier Source: org_study_id

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