The Efficacy of an Innovative Eye Shield to Improve Positioning Compliance in Gas or Oil Filled Eye

Phase 2

Recruiting

• Conditions: Positioning Compliance after Gas or Oil Filled procedure in macular hole or retinal detachment surgery; face- down position; gas filled eye; macular hole; retinal break; safety; eyeshield

• Registration Number: TCTR20190226005
• Lead Sponsor: Ratchadapiseksompotch fund, faculty of medicine, King Chulalongkorn Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-26
• Study Completion: 2019-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- Diagnosed rhagmatogenous retinal disease or macula hole
- Required gas/oil temponade procedure
- Required a specific post-operative positiong
- Fellow eye has BCVA better than 20/40 (scnellen) or LogMar 0.3 (ETRS)

Exclusion Criteria

- Required procedure in both eyes
- Neck injury/ surgery in recent 3 months
- Cannot obey the protocol: remaon head positioning for 7 days consecutively
- Be a part of the investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Deviated positioning time recored in percentage over 7 days percent of deviated positioning time per overall detected time

Secondary Outcome Measures

Name	Time	Method
BCVA at 1 and 3 months follow up EDTRS chart (LogMARS scale),MH closure rate at 1 and 3 months follow up OCT macula