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CompletedNCT06915948GiantMH-SOUpdated Apr 8, 2025

Postoperative Same Day Closure of Giant Macular Hole With Silicone Oil

An observational study in Macular Holes and Vitrectomy, sponsored by Ahalia Foundation Eye Hospital. Completed at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by Ahalia Foundation Eye Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
32
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Macular Holes
  • Vitrectomy

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Keywords

  • Macular Hole
  • Giant Large Macular Hole
  • Silicone Oil
  • SD-OCT
03

In context

Retinal Perforations

139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 43 observational studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Ahalia Foundation Eye Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

-Patients (South Indians) who attended Retina OPD in Ahalia Foundation Eye Hospital, Palakkad, Kerala was selected to participate in the study

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Patients who underwent surgery

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
32 participants (actual)
Patient registry
No

Interventions

  • ProcedureMacular Hole Surgery

    Pars Plana Vitrectomy with ILM peeling with silicone oil tamponade

06

What researchers measure

Primary outcomes

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

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

    Time frame: Day 1

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

    * 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

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

  3. Percentage of eyes having Type II Closure of Macular hole

    * 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

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

  4. Percentage of eyes having Open Macular hole

    * 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

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

  5. Adverse events

    Any adverse events

    Time frame: Day 1

Secondary outcomes

  1. Percentage of eyes with Anatomical Closure of Macular hole

    * 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

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

  2. Role of Hole Forming Factor (HFF) in predicting Hole Closure

    * Number of eyes with HFF \<0.5 achieving hole closure * Number of eyes with HFF \>0.5 achieving hole closure

    Time frame: at day 1, 2 weeks post surgery

  3. Role of Diameter Hole Index (DHI) in predicting Hole Closure

    * Number of eyes with DHI \<0.5 achieving hole closure * Number of eyes with DHI \>0.5 achieving hole closure

    Time frame: at day 1, 2 weeks post surgery

  4. Mean Diameter Hole Index

    * 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

    Time frame: 2 weeks post surgery

  5. Mean Hole Forming Factor

    * 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

    Time frame: 2 weeks post surgery

  6. 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

    Time frame: Pre-operative (baseline) and 1 month post Silicone oil removal

  7. Resurgeries

    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

  8. Reopened Holes

    Number of hole reopen cases , even under silicone oil

    Time frame: 6 months

  9. Adverse events

    Any adverse events in 3 months follow up .

    Time frame: 3 months

  10. Face down positioning

    To find out relevance for maintaining face down positioning

    Time frame: 1 month

07

Study locations

1 site
  • Ahaliafoundation Eye Hospital
    Palakkad, Kerala 678557, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2021 to primary completion in Apr 2023, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2024
First posted
Apr 8, 2025
StartActual
May 1, 2021
Primary completionActual
Apr 30, 2023
CompletionActual
Sep 30, 2023
Last update
Apr 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06915948
Lead sponsor
Ahalia Foundation Eye Hospital
Responsible party
Dr. Saurav Mahajan (Principal Investigator, Clinical Professor Adjunct, Ahalia Foundation Eye Hospital) — Principal investigator
First posted
Apr 8, 2025
Start date
May 1, 2021
Primary completion
Apr 30, 2023
Completion
Sep 30, 2023
Last update
Apr 8, 2025

Study contacts

Rajkumar Maheshwari, MS
principal investigator · Ahalia Foundation Eye Hospital
Amrutha S, DNB
principal investigator · Ahalia Foundation Eye Hospital
Saurav Mahajan, MS
principal investigator · Ahalia Foundation Eye Hospital
Sajeev C Jacob, MS
study chair · Ahalia Foundation Eye Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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