Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

• Sponsor: Helse Stavanger HF (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02295943
• Collaborator: Haukeland University Hospital (Other), Trondheim University Hospital (Other), University Hospital of North Norway (Other)
• Enrollment: 205
• Locations: 4
• Arm: 1
• Actual Duration (Months): 36.6
• Patients Per Site: 51.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Macular Hole	Other: Positioning measuring device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
• Actual Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Nov 20, 2017
• Actual Study Completion Date: Nov 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Positioning measuring device The supine time during the first postoperative day is measured	Other: Positioning measuring device; Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured

Outcome Measures

Primary Outcome Measures

1. Macular hole closure [2 weeks]

Secondary Outcome Measures

1. Time in supine sleeping position [1 day after enrollment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway	5021
2	Stavanger University Hospital	Stavanger		Norway	4011
3	University Hospital of North Norway	Tromsø		Norway	9038
4	Trondheim University Hospital	Trondheim		Norway	7030

Sponsors and Collaborators

• Helse Stavanger HF
• Haukeland University Hospital
• Trondheim University Hospital
• University Hospital of North Norway

Investigators

• Principal Investigator: Vegard Forsaa, MD, Stavanger University Hospital, Department of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helse Stavanger HF
• ClinicalTrials.gov Identifier: NCT02295943
• Other Study ID Numbers: 2014/879
• First Posted: Nov 20, 2014
• Last Update Posted: Jun 6, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Retinal Perforations

Study Results

No Results Posted as of Jun 6, 2018