Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02748421
Enrollment
30
Registered
2016-04-22
Start date
2016-05-31
Completion date
2017-07-31
Last updated
2016-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

retina surgery, image guided surgery, optical coherence tomography assisted

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.

Interventions

macular membrane dissection with OCT RESCAN

macular membrane dissection without OCT RESCAN

Sponsors

Instituto Paulista de Estudos e Pesquisa em Oftalmologia
CollaboratorOTHER
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assess optimal maneuvers in macular membrane dissectionDay 0 (surgical day)by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)

Secondary

MeasureTime frameDescription
Compare the time of surgery between groupsDay 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 dissectionDay 0by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)

Contacts

Primary ContactDiego Verginassi, MD
diegoverginassi@gmail.com5511-985564262
Backup ContactLuci Silva
luci.pesquisa@gmail.com+551155726443

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026