Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04527848

Enrollment

Registered

2020-08-27

Start date

2016-05-10

Completion date

2020-07-31

Last updated

2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Holes

Keywords

macular holes, Injections, Intra-Ocular, gases

Brief 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.

Interventions

DRUGsmall amount of undiluted C3F8

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

The individuals were randomized in a 1: 1: 1: 1 ratio. Block sizes of 4 individuals stratified according to gas type were used (SF6 or C3F8). In each block, two individuals were allocated to each group (0.9-1.0 mL of 100% gas or 15-20 mL of 20% gas).

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Gas duration	up to 60 days	duration of intraocular gas
macula hole closure	26 weeks	closure of the macular hole after the primary surgical procedure

Secondary

Measure	Time frame	Description
visual acuity	preoperative, 26 weeks	corrected distance visual acuity
intraocular pressure	preoperative, 1 day, 26 weeks	intraocular pressure

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026