An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Macular Hole Clinical Trial

Official title:

An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011165
• Other study ID #: REK2013/781
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: December 16, 2014
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators use the "tennis ball technique" where a tennis ball is fastened in the back of the night shirt in order to help patients compliance in avoiding the supine sleeping position. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to sleep two nights with the positioning measuring device, one night with a tennis ball in the back of the night shirt and one night without. Hereby the investigators search new knowledge concerning patients compliance and verification of the "tennis ball technique".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pars plana vitrectomy for macular hole, vitreomacular traction or epiretinal membrane where intra ocular gas tamponade is used.

• Informed consent

Exclusion Criteria:

• Age less than 18 years

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Hole
• Retinal Perforations

Intervention

Procedure:
• Positioning measuring device
A tennis ball in the night shirt will prevent supine position during sleep.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger University Hospital, Department of Ophthalmology	Stavanger

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Forsaa VA, Raeder S, Hashemi LT, Krohn J. Short-term postoperative non-supine positioning versus strict face-down positioning in macular hole surgery. Acta Ophthalmol. 2013 Sep;91(6):547-51. doi: 10.1111/j.1755-3768.2012.02464.x. Epub 2012 Jul 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in supine sleeping position		Two days	No