Optical Coherence Tomography - Rescan During Dissection of Macular Membranes

NCT ID: NCT02748421

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-07-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Lumera Microscope with OCT RESCAN

Intervention Type: PROCEDURE

macular membrane dissection with OCT RESCAN

Conventional Microscope

control group without OCT RESCAN

Group Type: OTHER

Conventional Microscope

Intervention Type: PROCEDURE

macular membrane dissection without OCT RESCAN

Interventions

Lumera Microscope with OCT RESCAN

macular membrane dissection with OCT RESCAN

Intervention Type: PROCEDURE

Conventional Microscope

macular membrane dissection without OCT RESCAN

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Paulista de Estudos e Pesquisa em Oftalmologia

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Michel Eid Farah

Michel Eid Farah

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Farah, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo UNIFESP

Central Contacts

Diego Verginassi, MD

Role: CONTACT

diegoverginassi@gmail.com

5511-985564262

Luci Silva

Role: CONTACT

luci.pesquisa@gmail.com

+551155726443

Other Identifiers

50991615.6.0000.5505

Identifier Type: -

Identifier Source: org_study_id