Positioning after idiopathic macular hole surgery
| ISRCTN | ISRCTN21076960 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21076960 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/01/2008
- Registration date
- 30/01/2008
- Last edited
- 18/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Catherine Creuzot-Garcher
Scientific
Scientific
Service d'Ophtalmologie
University Hospital Dijon (CHU) General Hospital
Dijon
21000
France
Study information
| Study design | Prospective, comparative, randomized controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Comparison of face-down and seated position after idiopathic macular hole surgery |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2004 |
| Completion date | 01/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 patients |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- France
Study participating centre
Service d'Ophtalmologie
Dijon
21000
France
21000
France
Sponsor information
Burgundy Association for Research in Ophthalmology (ABPRO) (France)
Research organisation
Research organisation
Service d'Ophtalmologie
University Hospital Dijon (CHU) General Hospital
Dijon
21000
France
| Website | http://www.chu-dijon.fr/index.htm |
|---|
Funders
Funder type
Research organisation
Burgundy Association for Research in Ophthalmology (ABPRO) (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/07/2008 | Yes | No |
