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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01974310
Other study ID # MH-FDP-non-FDP
Secondary ID
Status Completed
Phase N/A
First received October 26, 2013
Last updated February 10, 2016
Start date October 2013
Est. completion date March 2015

Study information

Verified date February 2016
Source Glostrup University Hospital, Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial.

Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date March 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Idiopathic macular hole stage II-IV

- Informed consent

- Duration of symptoms = 24 months

Exclusion Criteria:

- Previous vitreomacular surgery

- Myopia = 8 diopters

- Ocular trauma

- Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Vitrectomy & Intraocular gas fill

Postoperative face-down positioning


Locations

Country Name City State
Denmark Glostrup Hospital, University of Copenhagen Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Frequency of the complications During 3 months Yes
Primary Macular hole closure rate Macular hole closure rate assessed by optical coherence tomography 3 months No
Secondary ETDRS Visual Acuity Gain 3 months No
Secondary Degree of postoperative head incline Position Sensor 3 days No
Secondary Degree of ocular gas fill 4 days No
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