Impact of C3F8 or SF6 Use and Length of Face-down Positioning (7 vs 14 Days Respectively) in Macular Hole Surgery

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073266
• Other study ID #: 2012-1429, DR-002-1266
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: July 25, 2016
• Start date: January 2010
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study was to compare the macular hole closure and visual acuity gain following vitrectomy using SF6 gas tamponade with 7 days of face-down positioning versus C3F8 gas tamponade with 14 days of face-down positioning.

The secondary purpose was to report, in each group, the cumulative incidence of cataract development 1 year following macular hole surgery and the proportion of complications (*).

((*) hypertony, hypotony, retinal tear, retinal detachment and endophthalmitis) This prospective randomized study examined a 3 year period. The first patient was included in January 2010 and the last in November 2011. The 12-month follow-up spread out from March 2011 to December 2012. The first group included 31 patients who had undergone macular hole surgery using SF6 gas and who were advised to stay in face-down position for 7 days postoperatively (SF6 group). These patients were compared to 28 patients who had undergone macular hole surgery with C3F8 gas and who were advised to maintain a face-down position for 14 days. Patients in both groups underwent vitrectomy, internal limiting membrane peeling, and fluid-gas exchange using either SF6 or C3F8.

Preoperative data included the characterization of the hole with Optical Coherence Tomography (OCT), the best correct visual acuity (VA) recorded in number of letters using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, classification of the cataract according to the LOCS III and the intraocular pressure IOP. Postoperative data included OCT confirmation of the closure at 6 weeks and 1 year, 1 year's best corrected VA recorded in number of letters (EDTRS chart) and determination of cataract development and extraction as needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 51 Years to 83 Years

Eligibility

Inclusion Criteria:

• Idiopathic MH of stage 2-4 according to Gass classification (confirmed by fundoscopic examination and OCT) was included.

Exclusion Criteria:

• Exclusion criteria includes: patients with a chronic macular hole (symptoms more than 12 months duration), base diameter of the hole larger than 0.5 disc area diameter, medias opacities that prevent fundus visualisation until the second branches of central retinal artery, age-related macular degeneration ARMD, diabetic retinopathy, past history of retinal detachment or vitrectomy and corneal pathology disrupting vision.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Complications
• Macular Holes
• Retinal Perforations
• Visual Acuity Gain

Intervention

Procedure:
• Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8.

Locations

Country	Name	City	State
Canada	Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular hole closure and visual acuity gain	The primary purpose of the study was to compare the macular hole closure and visual acuity gain following vitrectomy using SF6 gas tamponade with 7 days of face-down positioning versus C3F8 gas tamponade with 14 days of face-down positioning.	1 year	Yes
Secondary	Cumulative incidence of cataract development and proportion of complications	The secondary purpose was to report, in each group, the cumulative incidence of cataract development 1 year following macular hole surgery and the proportion of complications.	1 year	Yes