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OpenTrials
Completed

NCT Number: NCT04527848

Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

To undertake a prospective randomized clinical trial of vitrectomy and gas tamponade to treat macular hole, utilizing a small amount of undiluted C3F8 (perfluoropropane) versus a large amount of diluted C3F8 versus a small amount of undiluted SF6 (sulfur hexafluoride) versus a large amount of diluted SF6.

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Key information

Conditions

Macular Holes Eye Diseases Retinal Diseases Retinal Perforations

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UFPE Ophthalmology

Recife, Pernambuco, 50740600, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pseudophakia
  • without previous vitreoretinal surgery
  • diagnosed with a full-thickness macula hole on the optical coherence tomography exam.
  • duration of symptoms less than 6 months
  • inform consent

Exclusion criteria

  • ocular trauma
  • allergy to any of the products used in the study,
  • need to travel by plane in the first 60 postoperative days
  • myopia over 6 diopters or axial diameter over 26 mm
  • retinal dystrophies
  • retinal detachment
  • abnormal eye shape
  • glaucoma
  • diabetic retinopathy or other eye comorbidities.

Treatment and study plan

small amount of undiluted C3F8

Drug

vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection

Primary outcomes

  1. Gas duration

    Time frame: up to 60 days

    duration of intraocular gas

  2. macula hole closure

    Time frame: 26 weeks

    closure of the macular hole after the primary surgical procedure

Secondary outcomes

  1. visual acuity

    Time frame: preoperative, 26 weeks

    corrected distance visual acuity

  2. intraocular pressure

    Time frame: preoperative, 1 day, 26 weeks

    intraocular pressure

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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