Positioning in macular hole surgery

Not Applicable

Completed

• Conditions: Disease: Ophthalmology; Eye Diseases; Topic: Ophthalmology; Subtopic: Eye (all Subtopics)

• Registration Number: ISRCTN12410596
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

2015 protocol in https://www.ncbi.nlm.nih.gov/pubmed/26576755 2017 statistical analysis plan in https://www.ncbi.nlm.nih.gov/pubmed/28610601 2020 results in https://pubmed.ncbi.nlm.nih.gov/32379288 (added 07/05/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-11
• Study Completion: 2017-12-31
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

1. Presence of idiopathic full-thickness macular hole, greater than or equal to 400 µm in diameter as measured OCT
2. Patients electing to have surgery for macular hole, with or without simultaneous phacoemulsification and intra-ocular lens implant
3. Ability and willingness to position face-down or in an inactive faceforward position
4. Lower age limit 18 years

Exclusion Criteria

1. Age-related macular degeneration; glaucoma; diabetic retinopathy; retinal degeneration; amblyopia; previous vitrectomy surgery (refractive error, lens opacity and previous use of ocriplasmin are not exclusion criteria)
2. Traumatic macular hole
3. History of visual loss suggesting macular hole duration longer than 12 months
4. Presence of a retinal tear identified during surgery for which post operative positioning is advised

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anatomical closure of the macular hole; Timepoint(s): Determined at three months after surgery by masked assessment of OCT scans.

Secondary Outcome Measures

Name	Time	Method
To determine the impact of face-down positioning on sight, quality of life and wellbeing.