NCT06915948

Postoperative Same Day Closure of Giant Macular Hole With Silicone Oil

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Ahalia Foundation Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 * The information recorded on the data collection forms were uploaded in an excel sheet and data were analyzed using IBM SPSS version 20. * To obtain the characteristic of categorical variables, frequency and percentage were applied. * To obtain the characteristic of numerical variables, mean and standard deviation were used. * Chi square test/ Fisher's exact test was used to find association between HFF, DHI, gender with hole closure type of closure. * Students t test and Man Whitney U test were performed to compare the average values of numerical parameters such as age, BCVA with hole closure, type of closure, HFF, DHI. * Paired t test was used to compare the pre-Op and Final BCVA. P-value \<0.05 was consideredto denote statistical significance. * ANOVA was used wherever we had to compare numerical data/means between 3 groups of type of hole closure- open vs type I vs type II closure.

Conditions

• Macular Holes
• Vitrectomy

Interventions

Type	Name	Description
PROCEDURE	Macular Hole Surgery	Pars Plana Vitrectomy with ILM peeling with silicone oil tamponade

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-04-30
• Completion: 2023-09-30
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: India