Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927430
• Other study ID #: SKC01/2019
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: Klinikum Chemnitz gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Epiretinal Membrane
• Macular Degeneration
• Macular Holes
• Retinal Perforations

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Chemnitz, Ophthalmology Department	Chemnitz	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Chemnitz gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with CNV	number of patients with CNV (choroidal neovascularization) development	last visit, in common 6 months postoperatively
Secondary	BCVA	best corrected visual acuity	last visit, in common 6 months postoperatively
Secondary	incidence of central retinal atrophy	development of central retinal atrophy on OCT	last visit, in common 6 months postoperatively