Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

NCT03927430 | Completed

• 1 other identifier: SKC01/2019
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Epiretinal Membrane; Macular Holes; Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• number of patients with CNV

  number of patients with CNV (choroidal neovascularization) development

  last visit, in common 6 months postoperatively

Secondary Outcomes (2)

• BCVA

  last visit, in common 6 months postoperatively

• incidence of central retinal atrophy

  last visit, in common 6 months postoperatively

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Chemnitz gGmbH: lead

Study Sites (1)

Klinikum Chemnitz, Ophthalmology Department

Chemnitz, Saxony, 09116, Germany

Location

MeSH Terms

Conditions

Epiretinal Membrane; Retinal Perforations; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Retinal Degeneration

Study Officials

• Katrin Engelmann, PhD

  Klinikum Chemnitz

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 25, 2019
• Study Start: January 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)