Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Macular Hole Clinical Trial

Official title:

Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02295943
• Other study ID #: 2014/879
• Status: Terminated
• Phase: N/A
• Start date: November 2014
• Est. completion date: November 20, 2017

Study information

• Verified date: June 2018
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to carry the positioning measuring device during the first postoperative 24 hours. Hereby the investigators search new knowledge concerning patients compliance and its relation to macular hole closure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 205
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary macular hole

• Duration less than 24 months

• Informed consent

Exclusion Criteria:

• Secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres)

• Previous vitreomacular surgery

• Age under 18 years

• Unable to sign

Related Conditions & MeSH terms

• Macular Hole
• Retinal Perforations

Intervention

Other:
• Positioning measuring device
Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger University Hospital	Stavanger
Norway	University Hospital of North Norway	Tromsø
Norway	Trondheim University Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Helse Stavanger HF	Haukeland University Hospital, Trondheim University Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular hole closure		2 weeks
Secondary	Time in supine sleeping position		1 day after enrollment