Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

Completed

• Conditions: Age Related Macular Degeneration; Macular Holes; Epiretinal Membrane

• Registration Number: NCT03927430
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-25
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of patients with CNV	last visit, in common 6 months postoperatively	number of patients with CNV (choroidal neovascularization) development

Secondary Outcome Measures

Name	Time	Method
incidence of central retinal atrophy	last visit, in common 6 months postoperatively	development of central retinal atrophy on OCT
BCVA	last visit, in common 6 months postoperatively	best corrected visual acuity

Trial Locations

Locations (1)

Klinikum Chemnitz, Ophthalmology Department; 🇩🇪 Chemnitz, Saxony, Germany