Optical Coherence Tomography - Rescan During Dissection of Macular Membranes

Evaluation Use Optical Coherence Tomography - Rescan During Dissection of Macular Membranes : Pre and Post Operative Aspects

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.

Study Overview

• Status: Unknown
• Conditions: Epiretinal Membrane; Proliferative Vitreoretinopathy; Macular Hole; Traction Syndrome Vitreomacular
• Intervention / Treatment: Procedure: Lumera Microscope with OCT RESCAN; Procedure: Conventional Microscope

Detailed Description

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.

Materials and methods The investigators will evaluate 30 patients with changes in macular membranes with surgical removal of indication from the Retina and Vitreous outpatient sector of Unifesp - Paulista School of Medicine. The patients will be classified according to the diseases in the following groups: Macular Hole, Epiretinal Membrane, Traction Syndrome vitreomacular, and proliferative vitreoretinopathy of Retinal Detachment. Everyone will be informed about the risks and benefits of the study and sign an informed consent form. In the preoperative evaluation a complete ophthalmologic examination with complementary tests such as angiography and optical coherence tomography will be done.

Patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding the identification and removal of macular membranes.

All patients will be assessed at 1, 7, 15, 30, 60 and 90 and 180 days after surgery, including the following tests:

• Measurement of visual acuity with best correction
• Previous Biomicroscopy
• Indirect Funduscopy
• tonometry
• Optical coherence tomography (OCT)
• Retinography Surgeries and procedures of the study groups will be conducted by the same team of surgeons and all surgeries and procedures will be carried out in IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.

For each type of retinal disease, there will be a control group and a group OCT as detailed below: 1 - GROUP CONTROL The control group will undergo retinal surgery with conventional microscope without coupled OCT. This group will have its filmed and documented surgery. The team of surgeons will answer the questionnaire on the surgical difficulty regarding the identification and removal of macular membranes.

2 -GROUP OCT / RESCAN In the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS and have their filmed and documented surgery. The team of surgeons will answer the questionnaire on the surgical difficulty regarding the identification and removal of macular membranes.

Statistical methodology All information will be presented by mean and standard deviation for the quantitative variables and absolute frequency (n) and relative (%) for qualitative variables.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diego Verginassi, MD; Phone Number: 5511-985564262; Email: diegoverginassi@gmail.com
• Study Contact Backup: Name: Luci Silva; Phone Number: +551155726443; Email: luci.pesquisa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

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

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lumera Microscope with OCT RESCAN; 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; macular membrane dissection with OCT RESCAN
Other: Conventional Microscope; control group without OCT RESCAN	Procedure: Conventional Microscope; macular membrane dissection without OCT RESCAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess optimal maneuvers in macular membrane dissection	by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)	Day 0 (surgical day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the time of surgery between groups	by a questionnaire responded by surgeons (until 1 hour, between 1-2 hours, more than 2 hours	Day 0 (surgical day)
describe the surgical difficulty for macular membrane dissection	by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)	Day 0

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Instituto Paulista de Estudos e Pesquisa em Oftalmologia
• Investigators: Principal Investigator: Michel Farah, MD, PhD, Federal University of São Paulo UNIFESP

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: image guided surgery; retina surgery; optical coherence tomography assisted
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Epiretinal Membrane; Vitreoretinopathy, Proliferative
• Other Study ID Numbers: 50991615.6.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: scientific publication