Positioning after idiopathic macular hole surgery

ISRCTN ISRCTN21076960
DOI https://doi.org/10.1186/ISRCTN21076960
Protocol serial number N/A
Sponsor Burgundy Association for Research in Ophthalmology (ABPRO) (France)
Funder Burgundy Association for Research in Ophthalmology (ABPRO) (France)
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

Service d'Ophtalmologie
University Hospital Dijon (CHU) General Hospital
Dijon
21000
France

Study information

Primary study designInterventional
Study designProspective, comparative, randomized controlled trial.
Secondary study designRandomised controlled trial
Scientific titleComparison of face-down and seated position after idiopathic macular hole surgery
Study objectivesTo 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) studiedIdiopathic macular hole
InterventionAll 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 Fluid–Air 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 typeOther
Primary outcome measure(s)

Anatomical closure of the hole after one surgical procedure confirmed by OCT. Timepoints of assessment: before, 3 and 6 months after the surgery.

Key secondary outcome measure(s)

Best corrected visual acuity change between the preoperative and the 6-month visit (expressed as LogMAR)

Completion date01/02/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration140
Key inclusion criteriaPatients 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 criteria1. 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 enrolment01/07/2004
Date of final enrolment01/02/2006

Locations

Countries of recruitment

  • France

Study participating centre

Service d'Ophtalmologie
Dijon
21000
France

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
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