Optical Coherence Tomography - Rescan During Dissection of Macular Membranes

NCT02748421 | Unknown

• 1 other identifier: 50991615.6.0000.5505
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

In our study , the investigators will use the microscope with OCT ( Lumera with RESCAN OCT ) coupled to assess the extent , depth and change of retinal architecture in the perioperative period . Thus , they will evaluate what the optimal maneuvers of dissection of macular membranes to obtain a more satisfactory result of the rearrangement in the retinal layers . Furthermore , the use of OCT perioperative may dispense with the use of dyes , decreasing the concentration used or reduce the exposure time. Thus, they can get the potential decrease in retinal toxicity may be generated by them.

Conditions

Macular Hole; Epiretinal Membrane; Traction Syndrome Vitreomacular; Proliferative Vitreoretinopathy

Keywords

retina surgery; image guided surgery; optical coherence tomography assisted

Outcome Measures

Primary Outcomes (1)

• Assess optimal maneuvers in macular membrane dissection

  by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)

  Day 0 (surgical day)

Secondary Outcomes (2)

• Compare the time of surgery between groups

  Day 0 (surgical day)

• describe the surgical difficulty for macular membrane dissection

  Day 0

Study Arms (2)

Lumera Microscope with OCT RESCAN

OTHER

in the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera microscope with Rescan OCT Zeiss

Procedure: Lumera Microscope with OCT RESCAN

Conventional Microscope

OTHER

control group without OCT RESCAN

Procedure: Conventional Microscope

Interventions

Lumera Microscope with OCT RESCAN PROCEDURE

macular membrane dissection with OCT RESCAN

Lumera Microscope with OCT RESCAN

Conventional Microscope PROCEDURE

macular membrane dissection without OCT RESCAN

Conventional Microscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Visual acuity less than 20/60 in the affected eye
• years of both sexes
• diagnostics of the diseases Macular Hole,Epiretinal membrane,Traction Syndrome vitreomacular, vitreoretinopathy Proliferative Retina Detachment.
• Indication of vitreoretinal surgery

You may not qualify if:

• Any previous eye surgery in the study eye
• Better visual acuity than or equal to 20/60.
• Any previous infection affecting any eye structure. transport costs and feeding of patients will be the responsibility of the researchers.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Instituto Paulista de Estudos e Pesquisa em Oftalmologia: collaborator

MeSH Terms

Conditions

Retinal Perforations; Epiretinal Membrane; Vitreoretinopathy, Proliferative

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Michel Farah, MD, PhD

  Federal University of São Paulo UNIFESP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Verginassi, MD

CONTACT

5511-985564262; diegoverginassi@gmail.com

Luci Silva

CONTACT

+551155726443; luci.pesquisa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michel Eid Farah

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 22, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: April 22, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share