Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
42 participants
INTERVENTIONAL
2019-02-01
2020-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
small flap medium-sized macular hole (SFMM)
small flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um)
pars plana vitrectomy with ILM inverted flap
Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and \>2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.
large flap medium-sized macular hole (LFMM)
large flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um)
pars plana vitrectomy with ILM inverted flap
Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and \>2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.
small flap large-sized macular hole (SFLM)
small flap (1-2 disc-diameter) was performed in Large sized macular hole (\>400 um)
pars plana vitrectomy with ILM inverted flap
Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and \>2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.
large flap Large-sized macular hole (LFLM)
large flap (3-4 disc-diameter) was performed in large sized macular hole (\>400 um)
pars plana vitrectomy with ILM inverted flap
Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and \>2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pars plana vitrectomy with ILM inverted flap
Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and \>2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* myopic MHs,
* MH secondary to retinal detachment,
* long-standing MH\> 12 months
* previous retinal surgeries
* high myopia with an axial length \> 26.0 mm
* other ocular pathologies interfering with the interpretation of the OCT reports.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mansoura University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ophthalmic center
Al Mansurah, Dakahelia, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ILM flap size
Identifier Type: -
Identifier Source: org_study_id