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OpenTrials
Completed

NCT Number: NCT03927430

Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

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.

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Key information

Conditions

Epiretinal Membrane Age Related Macular Degeneration Eye Diseases Macular Degeneration Macular Holes Retinal Degeneration Retinal Diseases Retinal Perforations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Chemnitz, Ophthalmology Department

Chemnitz, Saxony, 09116, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • active CNV or history of CNV

Treatment and study plan

pars plana vitrectomy with membrane peeling

Procedure

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

Primary outcomes

  1. number of patients with CNV

    Time frame: last visit, in common 6 months postoperatively

    number of patients with CNV (choroidal neovascularization) development

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Klinikum Chemnitz gGmbH

Other

Registry information

Official study title

To Peel or Not to Peel: Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2019
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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