Macular HoleNCT02748421
Optical Coherence Tomography - Rescan During Dissection of Macular Membranes
A study testing Lumera Microscope with OCT RESCAN and Conventional Microscope in people with Macular Hole and Epiretinal Membrane, run by Federal University of São Paulo.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Hole, Epiretinal Membrane, Traction Syndrome Vitreomacular
- What is being tested?
- Lumera Microscope with OCT RESCAN and Conventional Microscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Lumera Microscope with OCT RESCAN, Conventional Microscope
- Keywords
- retina surgery, image guided surgery, optical coherence tomography assisted
- Medical subject headings
- Retinal Perforations, Epiretinal Membrane, Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumera Microscope with OCT RESCANProcedure or surgery
macular membrane dissection with OCT RESCAN
Conventional MicroscopeProcedure or surgery
macular membrane dissection without OCT RESCAN
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Lumera Microscope with OCT RESCAN |
| Conventional Microscope | Other | control group without OCT RESCAN Receives: Procedure: Conventional Microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess optimal maneuvers in macular membrane dissection
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
Measured: Day 0 (surgical day)
Secondary outcomes (2)
Compare the time of surgery between groups
by a questionnaire responded by surgeons (until 1 hour, between 1-2 hours, more than 2 hours
Measured: Day 0 (surgical day)
describe the surgical difficulty for macular membrane dissection
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Paulista de Estudos e Pesquisa em Oftalmologia
- Responsible party
- Principal investigator, Michel Eid Farah, Federal University of São Paulo
- Investigators
- Michel Farah, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748421
- Sponsor's protocol ID
- 50991615.6.0000.5505
- Status last verified
- Apr 2016
- First submitted
- 6 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: scientific publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Use Optical Coherence Tomography - Rescan During Dissection of Macular Membranes : Pre and Post Operative Aspects
- ClinicalTrials.gov ID
- NCT02748421
- Acronym / sponsor ID
- 50991615.6.0000.5505
- Conditions
- Macular Hole, Epiretinal Membrane, Traction Syndrome Vitreomacular, Proliferative Vitreoretinopathy
- Keywords
- retina surgery, image guided surgery, optical coherence tomography assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Instituto Paulista de Estudos e Pesquisa em Oftalmologia
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumera Microscope with OCT RESCAN | Other | Procedure: Lumera Microscope with OCT RESCANin the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera microscope with Rescan OCT Zeiss |
| Conventional Microscope | Other | Procedure: Conventional Microscopecontrol group without OCT RESCAN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumera Microscope with OCT RESCANmacular membrane dissection with OCT RESCAN | Procedure or surgery | Lumera Microscope with OCT RESCAN |
| Conventional Microscopemacular membrane dissection without OCT RESCAN | Procedure or surgery | Conventional Microscope |
Primary outcome
Assess optimal maneuvers in macular membrane dissection
Time frame: Day 0 (surgical day)
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
2 secondary outcomes
Compare the time of surgery between groups
Time frame: Day 0 (surgical day)
describe the surgical difficulty for macular membrane dissection
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Individual participant dataSharing planned: Yes. scientific publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Farah, MD, PhD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Lumera Microscope with OCT RESCAN and Conventional Microscope in people with Macular Hole and Epiretinal Membrane, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Verginassi, MD (5511-985564262, diegoverginassi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess optimal maneuvers in macular membrane dissection (time frame: Day 0 (surgical day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.