Ahaliafoundation Eye Hospital
Palakkad, Kerala, 678557, India
NCT Number: NCT06915948
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
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Notify Me18 year–80 year
All sexes
Observational
Palakkad, Kerala, 678557, India
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pars Plana Vitrectomy with ILM peeling with silicone oil tamponade
Time frame: Day 1
Percentage (%) of eyes with Immediate Anatomical Closure of Macular hole on same day
Time frame: Day 1; 2 weeks after surgery ; 1 month post silicone oil removal
Time frame: At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal
Time frame: At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal
Time frame: Day 1
Any adverse events
Time frame: 2 weeks post surgery , 1 month Post Silicone oil removal
Time frame: at day 1, 2 weeks post surgery
Time frame: at day 1, 2 weeks post surgery
Time frame: 2 weeks post surgery
Time frame: 2 weeks post surgery
Time frame: Pre-operative (baseline) and 1 month post Silicone oil removal
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
Time frame: 6 months
No. of eyes that underwent resurgery for open macular hole No. of eyes that underwent resurgery for reason other than open macular hole
Time frame: 6 months
Number of hole reopen cases , even under silicone oil
Time frame: 3 months
Any adverse events in 3 months follow up .
Time frame: 1 month
To find out relevance for maintaining face down positioning
Ahalia Foundation Eye Hospital
Other
Postoperative Anatomical Closure of Idiopathic Chronic Giant Macular Hole on the Same Day Determined by Spectral Domain Optical Coherence Tomography for Macular Hole Surgery With Silicone Oil Tamponade
Acronym: GiantMH-SO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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