Optical Coherence Tomography - Rescan During Dissection of Macular Membranes

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT02748421

Collaborator

Instituto Paulista de Estudos e Pesquisa em Oftalmologia (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Hole Epiretinal Membrane Traction Syndrome Vitreomacular Proliferative Vitreoretinopathy	Procedure: Lumera Microscope with OCT RESCAN Procedure: Conventional Microscope	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Jul 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Assess optimal maneuvers in macular membrane dissection [Day 0 (surgical day)]
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.