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

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.

Study Overview

• Status: Completed
• Conditions: Macular Diseases
• Intervention / Treatment: Device: iOCT

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • VIROS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: study arm; iOCT is performed	Device: iOCT; the number of subjects that can be peeled without dye are assessed; Other Names: intraoperative OCT (iOCT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peeling without staining	number of patients that could be peeled without use of a dye	intraoperative (10-15 minutes)

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery
• Investigators: Principal Investigator: Oliver Findl, Prof, Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: vitreomacular traction syndrome; Epiretinal membrane; macular holes; lamellar holes of the macula
• Other Study ID Numbers: iOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED