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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1312-4425 | Other Identifier | WHO UTN |
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Patients with stage 3 and 4 macular holes of size >700 microns who underwent pars plana vitrectomy, Internal limiting Membrane peeling and silicone oil tamponade were followed at day 1 , 2 weeks and 1 month post silicone oil removal and anatomical closure of macular hole assessed at all intervals
Patients who attended Retina OPD in Ahalia Foundation Eye Hospital, Palakkad were selected to participate in the study
Basic demographic profile which includes name, age, gender , address was noted .
Structured questionnaire was used to collect information about the presence of any systemic risk factors like diabetes mellitus, hypertension, any prior retinal surgery and high myopia .
Preoperatively , all subjects will be tested for BCVA , intraocular pressure measurement, slit lamp bio-microscopy of anterior segment and indirect non contact bio-microscopy of the fundus with 20D lens will be documented .
Using spectral domain optical coherence tomography diagnosis of macular hole was confirmed and hole form factor and diameter hole index calculated based on the findings in optical coherence tomography.
Patients with stage 3 and 4 macular holes of size >700 u who underwent pars plana vitrectomy, ILM peeling and silicone oil tamponade were shortlisted.
Patients follow up was done on day 1, 2 weeks and 1 month post silicone oil removal .
For each follow up , BCVA with silicon oil and intraocular pressure was measured and indirect noncontact bio-microscopy examination of the macula was examined. Assessment of macula was done using OCT on day 1, 2 weeks and 1 month post silicone oil removal .
In all patients the anatomical closure of macular hole was assessed on day 1, 2 weeks and 1 month post silicone oil removal .
Statistical methods
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macular Hole Surgery | Procedure | Pars Plana Vitrectomy with ILM peeling with silicone oil tamponade |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes with Immediate Anatomical Closure of Macular hole | Percentage (%) of eyes with Immediate Anatomical Closure of Macular hole on same day | Day 1 |
| Percentage of eyes having Type I Closure of Macular hole |
| Day 1; 2 weeks after surgery ; 1 month post silicone oil removal |
| Percentage of eyes having Type II Closure of Macular hole |
| At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal |
| Percentage of eyes having Open Macular hole |
| At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal |
| Adverse events | Any adverse events | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes with Anatomical Closure of Macular hole |
| 2 weeks post surgery , 1 month Post Silicone oil removal |
| Role of Hole Forming Factor (HFF) in predicting Hole Closure |
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Inclusion Criteria:
Exclusion Criteria:
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-Patients (South Indians) who attended Retina OPD in Ahalia Foundation Eye Hospital, Palakkad, Kerala was selected to participate in the study
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| Name | Affiliation | Role |
|---|---|---|
| Rajkumar Maheshwari, MS | Ahalia Foundation Eye Hospital | Principal Investigator |
| Amrutha S, DNB | Ahalia Foundation Eye Hospital | Principal Investigator |
| Saurav Mahajan, MS | Ahalia Foundation Eye Hospital | Principal Investigator |
| Sajeev C Jacob, MS | Ahalia Foundation Eye Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahaliafoundation Eye Hospital | Palakkad | Kerala | 678557 | India |
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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|
| at day 1, 2 weeks post surgery |
| Role of Diameter Hole Index (DHI) in predicting Hole Closure |
| at day 1, 2 weeks post surgery |
| Mean Diameter Hole Index |
| 2 weeks post surgery |
| Mean Hole Forming Factor |
| 2 weeks post surgery |
| Visual Outcomes | Visual Acuity In LogMAR (logarithm of the Minimum Angle of Resolution) units Pre-operatively (baseline) and after 1 month of silicone oil removal excluding eyes that needed resurgery | Pre-operative (baseline) and 1 month post Silicone oil removal |
| Resurgeries | No. of eyes that underwent resurgery for open macular hole No. of eyes that underwent resurgery for reason other than open macular hole | 6 months |
| Reopened Holes | Number of hole reopen cases , even under silicone oil | 6 months |
| Adverse events | Any adverse events in 3 months follow up . | 3 months |
| Face down positioning | To find out relevance for maintaining face down positioning | 1 month |