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. 2023 Aug 7;2023(8):CD015031. doi: 10.1002/14651858.CD015031.pub2

CTRI/2017/05/008663.

Study name Comparative study between the conventional surgery versus a new surgical technique for treatment of macular holes
Methods Study design: single‐center parallel‐group RCT
Number randomized

  • Total: 30 in total

  • PPV with interred ILM flap: 15

  • Standard PPV with air: 15


Exclusions after randomization: none reported
Unit of analysis: none reported
Handling of missing data: NR
Participants Country: India
Inclusion criteria

  • Age > 18 years

  • Non‐traumatic idiopathic MH

  • Minimum diameter > 600 μm

  • MH Index ≤ 0.4

  • Phakic/Pseudophakic eyes

  • Informed consent


Exclusion criteria

  • Optic disc disease (e.g. glaucoma, age‐related macular degeneration, optic atrophy due to other causes)

  • Diabetic retinopathy or maculopathy

  • Retinal detachment

  • Lens opacity or cataract

  • Inability to adhere to follow‐up appointments


Types of MH in the study: idiopathic
Interventions Intervention: PPV with ILM inverted flap (type of inverted flap technique: NR)
Control: PPV with ILM peeling
Planned follow‐up: 1 week, 1 month, 3 months
Type of tamponade: NR
Outcomes Primary outcomes

  • BCVA

  • SD‐OCT


Secondary outcomes

  • Autofluorescence imaging

  • Multifocal ERG

  • Microperimetry

  • Fundus photo


Time points of outcome measurement: 1 week, 1 month, 3 months
Starting date 1 April 2016 to 1 June 2018 (estimated)
Contact information Manasa S. Centre for Ophthalmic Sciences, All India Institute Of Medical Sciences. Email: sendtomanasa@gmail.com
Notes Sponsorship source: Dr Rajendra Prasad: Centre for Ophthalmic Sciences; All: India Institute of Medical Sciences, Ansari Nagar New Delhi, India