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

NCT ID: NCT02683694

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-08-31

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.

Conditions

Macular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study arm

iOCT is performed

Group Type: OTHER

iOCT

Intervention Type: DEVICE

the number of subjects that can be peeled without dye are assessed

Interventions

iOCT

the number of subjects that can be peeled without dye are assessed

Intervention Type: DEVICE

Other Intervention Names

intraoperative OCT (iOCT)

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Prim. Prof. Dr. Oliver Findl, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Findl, Prof

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery

Locations

VIROS

Vienna, , Austria

Countries

Austria

Other Identifiers

iOC

Identifier Type: -

Identifier Source: org_study_id