Macular HolesNCT02073266
Impact of C3F8 or SF6 Use and Length of Face-down Positioning (7 vs 14 Days Respectively) in Macular Hole Surgery
A study testing Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8. in people with Macular Holes and Visual Acuity Gain, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 51 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Holes, Visual Acuity Gain, Cataract
- What is being tested?
- Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Idiopathic MH of stage 2-4 according to Gass classification (confirmed by fundoscopic examination and OCT) was included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, Quebec, G1S 4L8
About this study
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 (*).
Read more
((*) 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.
- Conditions
- Macular Holes, Visual Acuity Gain, Cataract, Complications
- Being tested
- Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8.
- Medical subject headings
- Retinal Perforations, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SF6 vitrectomy | Active comparator | 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. Receives: 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. |
| C3F8 vitrectomy | Active comparator | 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Cinq-Mars, MD, FRCS(C), Principal investigator, Centre de recherche du CHU de Québec: Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073266
- Sponsor's protocol ID
- 2012-1429, DR-002-1266
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 26 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of C3F8 or SF6 Use and Length of Face-down Positioning (7 vs 14 Days Respectively) in Macular Hole Surgery
- ClinicalTrials.gov ID
- NCT02073266
- Acronym / sponsor ID
- 2012-1429, DR-002-1266
- Conditions
- Macular Holes, Visual Acuity Gain, Cataract, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SF6 vitrectomy | Active comparator | 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.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. |
| C3F8 vitrectomy | Active comparator | 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.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. |
Who may qualify
- Ages
- 51 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic MH of stage 2-4 according to Gass classification (confirmed by fundoscopic examination and OCT) was included.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8. | Procedure or surgery | C3F8 vitrectomy, SF6 vitrectomy |
Primary outcome
Macular hole closure and visual acuity gain
Time frame: 1 year
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 secondary outcome
Cumulative incidence of cataract development and proportion of complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Cinq-Mars, MD, FRCS(C) principal investigator
Centre de recherche du CHU de Québec: Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8. in people with Macular Holes and Visual Acuity Gain, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular hole closure and visual acuity gain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.