Macular Holes
Conditions
Keywords
macular holes
Brief summary
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH)
Detailed description
Patients with macular holes classified in stages 3 and 4 will be randomized into 2 groups. . In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed. The 20% sulfur hexafluoride (SF6) gas will be used as a tamponade agent in all surgeries, and patients will be instructed to avoid the prone position for 5 days. OCT images will be performed in the first 5 postoperative days and months 1, 3 and 6. The primary outcome is anatomic closure of the MH closure in the month 6. The second outcomes are: mean best corrected visual acuity (BCVA) at month 6, mean change in the BCVA at month 6; integrity of the perifoveal external limiting membrane and ellipsoid zone on Optical Coherence Tomography (OCT); MH closure rate over time in days; functional improvement of microperimetry Statistical analysis will be performed with Student t-test and the p-value of ≤ 0.05 is considered significant.
Interventions
PROCEDUREConventional ILM Peeling
peeling with complete removal of the internal limiting membrane (ILM)
PROCEDUREInverted ILM Peeling
the inverted ILM peeling technique - the technique of Inverted flap described by Michalewska, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\> Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart.
Exclusion criteria
* Macular holes secondary to ocular trauma, myopia or retinal detachment * Any previous treatment for the macular hole * Evidence on examination of any diabetic retinopathy * History or presence of wet or dry age macular degeneration (AMD) * Presence of epiretinal membrane or prior uveitis * Any ocular surgery within 3 months before baseline * Intra or periocular infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Anatomic closure | Month 6 post operative | Rate of anatomic macular hole closure in the OCT at month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA mean | Month 6 post operative | mean best corrected visual acuity (BCVA) at month 6 |
| BCVA change | Screening and Month 6 post operative | change in the BCVA at month 6 |
| Integrity Membrane measured in microns (μm) by OCT | Month 6 post operative | In the month 6, the area of discontinuity of the perifoveal external limiting membrane and ellipsoid zone in the OCT images will be measured in microns (μm) and correlated between groups |
Countries
Brazil
Contacts
Primary ContactMauricio Maia, MD, PhD
Backup ContactLuci p Silva, PhD, MBA
Outcome results
None listed