Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of face-down and seated position after idiopathic macular hole surgery
Acronym
Study hypothesis
To test whether a face-down position is required in every patient operated on idiopathic macular hole, whatever the size of the macular hole.
Ethics approval
Ethics Committee for Protection of Human Subjects in Biomedical Research, Bourgogne (Comité Consultatif de protection des personnes dans la recherche biomédicale de Bourgogne). Date of approval: 6 May 2004 (ref: 2004/26)
Study design
Prospective, comparative, randomized controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Idiopathic macular hole
Intervention
All patients are subjected to the same surgical procedure: an extensive three-port pars plana vitrectomy using 20-gauge instrumentation. A peristaltic or venturi pump is used with maximum vacuum set between 200 and 500 mmHg according to the surgeon's preference, to obtain posterior vitreous detachment. The posterior hyaloid is removed. Then the Internal Limiting Membrane (ILM) is systematically removed using microforceps without indocyanine green or any other dye. Vitrectomy is completed, especially at the vitreous base. Finally, total FluidAir Exchange (FAE) was performed and a nonexpanding mixture of air and SF6 (20%) is used for pneumatic tamponade in Idiopathic Macular Holes (IMHs) less than 500 µm, air and C2F6 (17%) in IMHs larger than 500 µm, and air and C3F8 (14%) in IMHs larger than 800 µm.
After there procedures, the patients were allocated to two groups. The P0 group is asked to keep a seated position and P1 patients a strict face-down position 8 h a day for 5 days.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Anatomical closure of the hole after one surgical procedure confirmed by OCT. Timepoints of assessment: before, 3 and 6 months after the surgery.
Secondary outcome measures
Best corrected visual acuity change between the preoperative and the 6-month visit (expressed as LogMAR)
Overall trial start date
01/07/2004
Overall trial end date
01/02/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with stage 2, 3 and 4 idiopathic macular holes according to a scale developed by Gass and confirmed by Optical Coherence Tomography (OCT)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140 patients
Participant exclusion criteria
1. Axial length longer than 27 mm
2. Previous macular surgical procedure
3. Stage I macular holes
4. Posttraumatic or other secondary macular holes
5. Inability to assume a correct face-down position
Recruitment start date
01/07/2004
Recruitment end date
01/02/2006
Locations
Countries of recruitment
France
Trial participating centre
Service d'Ophtalmologie
Dijon
21000
France
Sponsor information
Organisation
Burgundy Association for Research in Ophthalmology (ABPRO) (France)
Sponsor details
Service d'Ophtalmologie
University Hospital Dijon (CHU) General Hospital
Dijon
21000
France
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Burgundy Association for Research in Ophthalmology (ABPRO) (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18440484
Publication citations
-
Results
Guillaubey A, Malvitte L, Lafontaine PO, Jay N, Hubert I, Bron A, Berrod JP, Creuzot-Garcher C, Comparison of face-down and seated position after idiopathic macular hole surgery: a randomized clinical trial., Am. J. Ophthalmol., 2008, 146, 1, 128-134, doi: 10.1016/j.ajo.2008.02.029.