Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

NCT ID: NCT02295943

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Hole

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Positioning measuring device

The supine time during the first postoperative day is measured

Group Type OTHER

Positioning measuring device

Intervention Type OTHER

Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured

Interventions

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Positioning measuring device

Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

Trondheim University Hospital

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vegard Forsaa, MD

Role: PRINCIPAL_INVESTIGATOR

Stavanger University Hospital, Department of Ophthalmology

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Stavanger University Hospital

Stavanger, , Norway

Site Status

University Hospital of North Norway

Tromsø, , Norway

Site Status

Trondheim University Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Lindtjorn B, Krohn J, Austeng D, Fossen K, Varhaug P, Basit S, Helgesen OH, Eide GE, Forsaa VA. Nonsupine Positioning after Macular Hole Surgery: A Prospective Multicenter Study. Ophthalmol Retina. 2019 May;3(5):388-392. doi: 10.1016/j.oret.2018.12.006. Epub 2018 Dec 31.

Reference Type DERIVED
PMID: 31044728 (View on PubMed)

Other Identifiers

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2014/879

Identifier Type: -

Identifier Source: org_study_id

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