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Completed

NCT Number: NCT06915948

Postoperative Same Day Closure of Giant Macular Hole With Silicone Oil

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahaliafoundation Eye Hospital

Palakkad, Kerala, 678557, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with idiopathic chronic giant macular hole more than 700 micron size confirmed by indirect biomicroscopy and optical coherence tomography.
  • Patients who give a valid informed consent
  • Patients who underwent surgery

Exclusion criteria

  • High myopic patients ( >10 D)
  • Patients with history of ocular trauma
  • Patients with history of any macular surgery
  • Rhegmatogenous retinal detachment associated with macular hole
  • Patients having vision loss due to other ocular comorbidities- glaucoma , macular pathology or vitreous hemorrhage.

Treatment and study plan

Macular Hole Surgery

Procedure

Pars Plana Vitrectomy with ILM peeling with silicone oil tamponade

Primary outcomes

  1. Percentage of eyes with Immediate Anatomical Closure of Macular hole

    Time frame: Day 1

    Percentage (%) of eyes with Immediate Anatomical Closure of Macular hole on same day

  2. Percentage of eyes having Type I Closure of Macular hole

    Time frame: Day 1; 2 weeks after surgery ; 1 month post silicone oil removal

    • Percentage (%) of eyes having Type I Closure of Macular hole at Day 0
    • Percentage (%) of eyes having Type I Closure of Macular hole at 2 weeks
    • Percentage (%) of eyes having Type I Closure of Macular hole 1 month post Silicone oil removal in eyes undergoing Silicone oil removal
  3. Percentage of eyes having Type II Closure of Macular hole

    Time frame: At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal

    • Percentage (%) of eyes having Type II Closure of Macular hole at Day 0
    • Percentage (%) of eyes having Type II Closure of Macular hole at 2 weeks
    • Percentage (%) of eyes having Type II Closure of Macular hole 1 month post Silicone oil removal in eyes undergoing Silicone oil removal
  4. Percentage of eyes having Open Macular hole

    Time frame: At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal

    • Percentage (%) of eyes having Open Macular hole at Day 0
    • Percentage (%) of eyes having Open Macular hole at 2 weeks
    • Percentage (%) of eyes having Open Macular hole 1 month post Silicone oil removal in eyes undergoing Silicone oil removal
  5. Adverse events

    Time frame: Day 1

    Any adverse events

Secondary outcomes

  1. Percentage of eyes with Anatomical Closure of Macular hole

    Time frame: 2 weeks post surgery , 1 month Post Silicone oil removal

    • Percentage (%) of eyes with Anatomical Closure of Macular hole at 2 week follow up
    • Percentage (%) of eyes with Anatomical Closure of Macular hole at 1 month post silicone oil removal
  2. Role of Hole Forming Factor (HFF) in predicting Hole Closure

    Time frame: at day 1, 2 weeks post surgery

    • Number of eyes with HFF <0.5 achieving hole closure
    • Number of eyes with HFF >0.5 achieving hole closure
  3. Role of Diameter Hole Index (DHI) in predicting Hole Closure

    Time frame: at day 1, 2 weeks post surgery

    • Number of eyes with DHI <0.5 achieving hole closure
    • Number of eyes with DHI >0.5 achieving hole closure
  4. Mean Diameter Hole Index

    Time frame: 2 weeks post surgery

    • Mean Preoperative Diameter Hole Index(DHI) in eyes with Type I closure of macular hole
    • Mean Preoperative Diameter Hole Index(DHI) in eyes with Type II closure of macular hole
    • Mean Preoperative Diameter Hole Index(DHI) in eyes with Open macular hole
  5. Mean Hole Forming Factor

    Time frame: 2 weeks post surgery

    • Mean Preoperative Hole Forming Factor(HFF) in eyes with Type I closure of macular hole
    • Mean Preoperative Hole Forming Factor(HFF) in eyes with Type II closure of macular hole
    • Mean Preoperative Hole Forming Factor(HFF) in eyes with Open macular hole
  6. Visual Outcomes

    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

  7. Resurgeries

    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

  8. Reopened Holes

    Time frame: 6 months

    Number of hole reopen cases , even under silicone oil

  9. Adverse events

    Time frame: 3 months

    Any adverse events in 3 months follow up .

  10. Face down positioning

    Time frame: 1 month

    To find out relevance for maintaining face down positioning

Sponsors and collaborators

Lead sponsor

Ahalia Foundation Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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