Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a Randomised Controlled Trial: FILMS
2008

Study on ILM Peeling for Macular Holes

Sample size: 140 publication 10 minutes Evidence: moderate

Author Information

Author(s): Lois Noemi, Burr Jennifer, Norrie John, Vale Luke, Cook Jonathan, McDonald Alison

Primary Institution: University of Aberdeen

Hypothesis

ILM peeling is superior to the non-peeling procedure with regards to improving vision and quality of life, achieving macular hole closure and that it is cost effective.

Conclusion

The FILMS study aims to provide high-quality evidence on the effectiveness of ILM peeling in macular hole surgery.

Supporting Evidence

  • ILM peeling may improve visual and anatomical success in macular hole surgery.
  • Randomised controlled trials have shown surgery is effective for stage 2, 3, and 4 FTMH.
  • Previous studies suggest ILM peeling could lead to better outcomes, but robust evidence is lacking.

Takeaway

This study is trying to find out if a specific eye surgery technique helps people see better and feel better after having a hole in their eye.

Methodology

Participants with stage 2-3 idiopathic FTMH will be randomized to receive surgery with or without ILM peeling, and outcomes will be measured at multiple time points.

Potential Biases

There may be risks of bias in participant selection and outcome assessment due to the nature of the surgical intervention.

Limitations

The study may have limitations related to participant recruitment and the generalizability of the findings.

Participant Demographics

Participants will be adults with idiopathic FTMH, aged 18 months or less, with specific visual acuity criteria.

Statistical Information

P-Value

0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1745-6215-9-61

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication