Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

To Peel or Not to Peel: 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.

Study Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration; Epiretinal Membrane; Macular Holes
• Intervention / Treatment: Procedure: pars plana vitrectomy with membrane peeling

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Chemnitz, Saxony, Germany, 09116
      • Klinikum Chemnitz, Ophthalmology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

mostly elderly people, mean age 66 years, both males and females

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with CNV	number of patients with CNV (choroidal neovascularization) development	last visit, in common 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA	best corrected visual acuity	last visit, in common 6 months postoperatively
incidence of central retinal atrophy	development of central retinal atrophy on OCT	last visit, in common 6 months postoperatively

Collaborators and Investigators

• Sponsor: Klinikum Chemnitz gGmbH
• Investigators: Study Chair: Katrin Engelmann, PhD, Klinikum Chemnitz

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Retinal Perforations; Epiretinal Membrane
• Other Study ID Numbers: SKC01/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No