Postoperative Positioning After Surgery for Macular Holes

Macular Holes Clinical Trial

Official title:

A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974310
• Other study ID #: MH-FDP-non-FDP
• 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

• Macular Holes
• Retinal Perforations

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