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

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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190226005
Enrollment
90
Registered
2019-02-26
Start date
2019-04-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Positioning Compliance after Gas or Oil Filled procedure in macular hole or retinal detachment surgery face&#45

Interventions

Patient wearing an innovative eye&#45
shield with switching ON the feedback alarm function. The eye&#45
shield will collect the head positioning and alert when head deviated from the designed angle.,Patient wearing an innovative eye&#45
shield with switching OFF the feedback alarm function. The eye&#45
shield will collect the head positioning.
Experimental Device,Sham Comparator Device
Switch&#45
ON feedback alarm group,Switch&#45
off feedback alarm group

Sponsors

Ratchadapiseksompotch fund, faculty of medicine, King Chulalongkorn Memorial Hospital
Lead Sponsor
&#45
Collaborator
,&#45
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Deviated positioning time recored in percentage over 7 days percent of deviated positioning time per overall detected time—

Secondary

MeasureTime frame
BCVA at 1 and 3 months follow up EDTRS chart (LogMARS scale),MH closure rate at 1 and 3 months follow up OCT macula—

Countries

Thailand

Contacts

Public ContactSopit Praiwattana

Ophthalmology department

sopit.p.p@gmail.com0894471125

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026