Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Macular Holes Clinical Trial

Official title:

Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527848
• Other study ID #: 12347319.9.0000.8807
• Status: Completed
• Phase: Phase 4
• Start date: May 10, 2016
• Est. completion date: July 31, 2020

Study information

• Verified date: December 2020
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Drug:
• small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection

Locations

Country	Name	City	State
Brazil	UFPE Ophthalmology	Recife	PE

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gas duration	duration of intraocular gas	up to 60 days
Primary	macula hole closure	closure of the macular hole after the primary surgical procedure	26 weeks
Secondary	visual acuity	corrected distance visual acuity	preoperative, 26 weeks
Secondary	intraocular pressure	intraocular pressure	preoperative, 1 day, 26 weeks