Condition category
Eye Diseases
Date applied
02/01/2008
Date assigned
30/01/2008
Last edited
18/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Catherine Creuzot-Garcher

ORCID ID

Contact details

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

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 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 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

http://www.chu-dijon.fr/index.htm

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

  1. 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.

Additional files

Editorial Notes