Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)

Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01020760

Enrollment

Registered

2009-11-26

Start date

2008-09-30

Completion date

2010-10-31

Last updated

2012-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full Thickness Macular Hole

Keywords

Macular hole, Vitrectomy, Prone posturing

Brief summary

The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.

Interventions

BEHAVIORALFace down posture

Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients having surgery for idiopathic full thickness macular hole 2. Able and willing to posture face-down for 10 days postoperatively 3. Agree to participate in the trial and able to give informed consent

Exclusion criteria

1. History of visual loss suggesting a duration of macular hole greater than 12 months 2. Patients unable or unwilling to posture face-down for 10 days postoperatively 3. History of trauma that may have been causative 4. Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years). 5. Previous vitrectomy surgery 6. Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.

Design outcomes

Primary

Measure	Time frame
estimate variance and effect size order to inform power calculations for further studies.	one year

Secondary

Measure	Time frame
visual acuity and complications	one year
estimate recruitment rate and establish protocol/procedure	one year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026