Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases

Not Applicable

Completed

• Conditions: Macular Diseases
• Interventions: Device: iOCT

• Registration Number: NCT02683694
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

Brief Summary

During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula.

Epiretinal membrane (ERM), lamellar macular hole, macular hole and vitreomacular traction syndrome are disorders involving the posterior pole of the eyeball with consecutive vision loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle, vitrectomy and membrane peeling is usually performed to remove traction and the ERM.

Different study groups showed that intraoperative use of SD-OCT is possible and improves the quality of peeling surgery.

Detailed Description

The aim of the study is to assess the benefits and limits of intraoperative OCT (i-OCT), for example whether I-OCT assisted membrane peeling is possible without use of dyes for enabling better localistion of the ERM during surgery and to compare that scheme with different "gold standard" dyes for peeling such as membrane blue dual and triamcinolone. Rationale for that study is to work out which setting enables best visualisation of ERM and ILM (ILM) in i-OCT. A limitation of that method seems to be visualisation of the inner limiting membrane, so that dying of the ILM will probably be still necessary in all cases where ILM-peeling is sheduled.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-17
• Primary Completion: 2017-05
• Study Completion: 2017-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Epiretinal Membrane, lamellar hole of the macula, macular hole and vitreomacular traction syndrome

Exclusion Criteria

• Other diseases of the eye, such as AMD, retinopathia pigmentosa

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study arm	iOCT	iOCT is performed

Primary Outcome Measures

Name	Time	Method
peeling without staining	intraoperative (10-15 minutes)	number of patients that could be peeled without use of a dye

Trial Locations

Locations (1)

VIROS; 🇦🇹 Vienna, Austria