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

Primary Purpose

Macular Holes, Visual Acuity Gain, Cataract

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8.
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Holes

Eligibility Criteria

51 Years - 83 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SF6 vitrectomy

C3F8 vitrectomy

Arm Description

The first group included 31 patients who had undergone MH surgery using SF6 gas and who were advised to stay in face-down position for 7 days postoperatively (SF6 group). Patients in both groups underwent 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8. The internal limiting membrane was coloured with trypan blue or indocyanine green in equal proportion in both groups.

The second group included 28 patients who had undergone MH surgery with C3F8 gas and who were advised to maintain a face-down position for 14 days. Patients in both groups underwent 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8. The internal limiting membrane was coloured with trypan blue or indocyanine green in equal proportion in both groups.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 25, 2014
Last Updated
July 25, 2016
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT02073266
Brief Title
Impact of C3F8 or SF6 Use and Length of Face-down Positioning (7 vs 14 Days Respectively) in Macular Hole Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes, Visual Acuity Gain, Cataract, Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SF6 vitrectomy
Arm Type
Active Comparator
Arm Description
The first group included 31 patients who had undergone MH surgery using SF6 gas and who were advised to stay in face-down position for 7 days postoperatively (SF6 group). Patients in both groups underwent 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8. The internal limiting membrane was coloured with trypan blue or indocyanine green in equal proportion in both groups.
Arm Title
C3F8 vitrectomy
Arm Type
Active Comparator
Arm Description
The second group included 28 patients who had undergone MH surgery with C3F8 gas and who were advised to maintain a face-down position for 14 days. Patients in both groups underwent 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8. The internal limiting membrane was coloured with trypan blue or indocyanine green in equal proportion in both groups.
Intervention Type
Procedure
Intervention Name(s)
Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8.
Primary Outcome Measure Information:
Title
Macular hole closure and visual acuity gain
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cumulative incidence of cataract development and proportion of complications
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
83 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit Cinq-Mars, MD, FRCS(C)
Organizational Affiliation
Centre de recherche du CHU de Québec: Université Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada

12. IPD Sharing Statement

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

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