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

CTRI/2017/03/008001.

Study name Comparison between standard surgical technique versus newer technique for large holes in the centre of the retina: a prospective randomised control trial
Methods Study design: single‐center parallel‐group RCT
Number randomized: 102 in total
Exclusions after randomization: none reported
Unit of analysis: NR
Handling of missing data: NR
Participants Country: India
Inclusion criteria
  • Age 40–80 years

  • Idiopathic MH or MH secondary to other etiology

  • MH size > 500 μm


Exclusion criteria
  • Previously failed MH surgery

  • MH size < 500 μm

  • Requirement for both IOL and MH surgery

  • Baseline OCT scan with signal strength < 5

  • Other ocular comorbidities that can affect final visual outcome

  • Monocular vision


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: 12 months
Type of tamponade: SF6
Outcomes Primary outcomes
  • MH closure


Secondary outcomes
  • Distance BCVA


Time points of outcome measurement: 12 months
Starting date 3 September 2017
Contact information Prabu Baskaran, Aravind Eye Hospital. Email: prabubaskaran@gmail.com
Notes Sponsorship source: Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry 605007, India