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Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

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ClinicalTrials.gov Identifier: NCT03927430
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Katrin Engelmann, Klinikum Chemnitz gGmbH

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 Intervention/treatment
Epiretinal Membrane Macular Holes Age Related Macular Degeneration Procedure: pars plana vitrectomy with membrane peeling

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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 1, 2019
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: 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


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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927430


Locations
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Germany
Klinikum Chemnitz, Ophthalmology Department
Chemnitz, Saxony, Germany, 09116
Sponsors and Collaborators
Klinikum Chemnitz gGmbH
Investigators
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Study Chair: Katrin Engelmann, PhD Klinikum Chemnitz

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Responsible Party: Katrin Engelmann, Head of Ophthalmology, 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Perforations
Epiretinal Membrane
Retinal Degeneration
Retinal Diseases
Eye Diseases
Temazepam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action