Full Thickness Macular Hole, Idiopathic Macular Hole, Macular Hole, Macular Holes
Conditions
Keywords
macular hole, pars plana vitrectomy, perfluoropropane (C3F8), sulfur hexafluoride (SF6), Idiopathic Macular Hole, Full thickness macular hole, large macular hole, large macular holes
Brief summary
The goal of this clinical trial is to evaluate the visual and anatomical outcomes of large (410-1000 μm) full-thickness macular holes repair surgery using perfluoropropane (15% C3F8), sulfur hexafluoride (20% SF6) gas tamponade.
Detailed description
The project is a randomized clinical trial with a follow up time of 6 months comparing the effects of surgical treatment of large (410-1000 μm) idiopathic macular holes. Patients are randomized to vitrectomy surgery with internal limiting membrane peeling using perfluoropropane (15% C3F8), sulfur hexafluoride (20% SF6) gas tamponad. Intra- and postoperative complications are registered.
Interventions
PROCEDUREPars plana vitrectomy
All operations are performed in a similar fashion using the vitrectomy system with 23-gauge and 25-gauge vitrectomy probes. Surgical approach and technique include the use of tissue-staining dyes, choice of endotamponade, and postoperative face-down positioning regimen.
Sponsors
Ukrainian Vitreoretinal Society
The Filatov Institute of Eye Diseases and Tissue Therapy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient age 50 or above. * Duration of Symptoms ≤ 12 months. * Macular holes having a diameter 410-1000 μm. * Informed consent.
Exclusion criteria
* Patients under 50 years of age. * A patient who has already undergone treatment (surgery, laser etc.) for any disease of the retina. * Traumatic or pediatric macular holes, and associated retinal detachment. * History of any retinal disease such as high myopia, retinal dystrophies, central serous retinopathy, retinal vascular diseases, diabetic retinopathy, uveitis etc. * Previous history of glaucoma or ocular hypertension. * Failure to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Closure of macular holes | 6 months | Closure of macular hole evaluated on optical coherence tomography |
| Type of macular hole closure | 6 months | U-, V-, W-types of macular hole closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected visual acuity | 6 months | Visual acuity measured at last follow-up |
Countries
Ukraine
Outcome results
None listed