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An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Sponsor
Helse Stavanger HF (Other)
Overall Status
Completed
CT.gov ID
NCT02011165
Collaborator
Haukeland University Hospital (Other)
43
Enrollment
2
Locations
14
Duration (Months)
21.5
Patients Per Site
1.5
Patients Per Site Per Month

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 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".

Condition or Disease Intervention/Treatment Phase
  • Procedure: Positioning measuring device

Study Design

Study Type:
Observational
Actual Enrollment :
43 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Tennis ball

Night with tennis ball fastened in the back of the night shirt. A positioning measuring device mounted.

Procedure: Positioning measuring device
A tennis ball in the night shirt will prevent supine position during sleep.
Other Names:
  • Measurement of time spent in the supine position

    		•
    No tennis ball

    Night without tennis ball fastened in the back of the night shirt. A positioning measure device mounted.

    Procedure: Positioning measuring device
    A tennis ball in the night shirt will prevent supine position during sleep.
    Other Names:
  • Measurement of time spent in the supine position

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time in supine sleeping position [Two days]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haukeland University Hospital Bergen Norway 5021
    2 Stavanger University Hospital, Department of Ophthalmology Stavanger Norway 4026

    Sponsors and Collaborators

    • Helse Stavanger HF
    • Haukeland University Hospital

    Investigators

    • Principal Investigator: Vegard Forsaa, MD, Helse Stavanger HF

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Helse Stavanger HF
    ClinicalTrials.gov Identifier:
    NCT02011165
    Other Study ID Numbers:
    • REK2013/781
    First Posted:
    Dec 13, 2013
    Last Update Posted:
    Dec 17, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Helse Stavanger HF
    Macular hole
    Vitrectomy
    Gas tamponade
    Vitreomacular traction in danger of macular hole formation
    Epiretinal membrane in danger of macular hole formation
    Additional relevant MeSH terms:
    Retinal Perforations

    Study Results

    No Results Posted as of Dec 17, 2014