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Macular HolesGiantMH-SONCT06915948

Postoperative Same Day Closure of Giant Macular Hole With Silicone Oil

An observational study of Macular Holes and Vitrectomy, run by Ahalia Foundation Eye Hospital at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Macular Holes, Vitrectomy
What is being tested?
Macular Hole Surgery
Type of treatment
Surgery or procedure
How many people
32 participants
Where
1 siteIndia
Study dates
1 May 2021to 30 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Ahaliafoundation Eye Hospital

    Palakkad, Kerala, 678557

Other trials in India

About this study

Official 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

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.
Being tested
Macular Hole Surgery
Keywords
Macular Hole, Giant Large Macular Hole, Silicone Oil, SD-OCT
Medical subject headings
Retinal Perforations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Macular Hole SurgeryProcedure or surgery

    Pars Plana Vitrectomy with ILM peeling with silicone oil tamponade

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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

    Measured: 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

    Measured: 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

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

  5. Adverse events

    Any adverse events

    Measured: Day 1

Secondary outcomes (10)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 6 months

  8. Reopened Holes

    Number of hole reopen cases , even under silicone oil

    Measured: 6 months

  9. Adverse events

    Any adverse events in 3 months follow up .

    Measured: 3 months

  10. Face down positioning

    To find out relevance for maintaining face down positioning

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start1 May 2021
  3. Primary completion30 Apr 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06915948
Sponsor's protocol ID
202103.
Other IDs
U1111-1312-4425
Acronym
GiantMH-SO
Status last verified
Apr 2025
First submitted
24 Aug 2024
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Macular Holes and Vitrectomy, run by Ahalia Foundation Eye Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of eyes with Immediate Anatomical Closure of Macular hole (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06915948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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