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Clinical Trials/ISRCTN12410596
ISRCTN12410596
Completed
未知

A multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning with an inactive face-forward position on the outcome of surgery for large macular holes

Moorfields Eye Hospital NHS Foundation Trust0 sites185 target enrollmentFebruary 11, 2015
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ConditionsTopic: OphthalmologySubtopic: Eye (all Subtopics)Disease: OphthalmologyEye Diseases

Overview

Phase
未知
Intervention
Not specified
Conditions
Topic: Ophthalmology
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Enrollment
185
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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)

Registry
who.int
Start Date
February 11, 2015
End Date
December 31, 2017
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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