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

Macular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683694
• Other study ID #: iOC
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: March 8, 2018
• Start date: February 2015
• Est. completion date: August 2017

Study information

• Verified date: March 2018
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Diseases

Intervention

Device:
• iOCT
the number of subjects that can be peeled without dye are assessed

Locations

Country	Name	City	State
Austria	VIROS	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peeling without staining	number of patients that could be peeled without use of a dye	intraoperative (10-15 minutes)