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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

Clinicaltrials.gov identifier NCT03927430

Recruitment Status Completed

First Posted April 25, 2019

Last update posted May 1, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Epiretinal Membrane
    Macular Holes
    Age Related Macular Degeneration
  • Intervention/Treatment: Procedure: pars plana vitrectomy with membrane peeling
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 40 participants
  • Observational Model: Case-Only
  • Time Perspective: Retrospective
  • Official Title: To Peel or Not to Peel: Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen
  • Actual Study Start Date: January 2019
  • Actual Primary Completion Date: March 2019
  • Actual Study Completion Date: March 2019
Outcome Measures
  • Primary Outcome Measures: 1. number of patients with CNV [ Time Frame: last visit, in common 6 months postoperatively ]
    number of patients with CNV (choroidal neovascularization) development
  • Secondary Outcome Measures: 1. BCVA [ Time Frame: last visit, in common 6 months postoperatively ]
    best corrected visual acuity
  • 2. incidence of central retinal atrophy [ Time Frame: last visit, in common 6 months postoperatively ]
    development of central retinal atrophy on OCT
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: mostly elderly people, mean age 66 years, both males and females
Criteria

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

Contacts and Locations
Contacts
Locations

Germany, Saxony
Klinikum Chemnitz, Ophthalmology Department
Chemnitz

Sponsors and Collaborators

Klinikum Chemnitz gGmbH

Investigators

Study Chair: Katrin Engelmann, PhD Klinikum Chemnitz

More Information
  • Responsible Party: Klinikum Chemnitz gGmbH
  • ClinicalTrials.gov Identifier: NCT03927430 History of Changes
  • Other Study ID Numbers: SKC01/2019
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: May 1, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Epiretinal Membrane
    Macular Degeneration
    Retinal Perforations