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A Comparative interventional study to see the difference in orbital volume correction in patient with eye floor defect post trauma using individualised implants vs stock implants

Comparative analysis of orbital volume using Patient Specific Implants vs preformed stock orbital implants in reconstruction of post traumatic residual orbital floor defect A Randomised Controlled Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092738
Enrollment
28
Registered
2025-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: S023- Fracture of orbital floor

Interventions

Intervention1: Patient Specific Orbital Implants: Use of Patient Specific Implants in patients with post traumatic orbital floor defect, one time intervention only when patient come to us with the orb

Sponsors

Government Schemes
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients requiring post traumatic orbital floor and/or medial walll repair Patient age >18 years Patient giving informed consent

Exclusion criteria

Exclusion criteria: Patients with fracture of orbital roof Bilateral orbital wall fracture (Mirroring not possible) Patient refusing consent for the study Pregnant Patient Monocular Diplopia with reasons other than muscle entrapment or volume increase Side of orbital defect being the only eye with intact vision Patient with neuromuscular disorders with influence on eye mobility Active malignancy Life threatening conditions

Design outcomes

Primary

MeasureTime frame
To evaluate orbital volume correctionTimepoint: Preoperatively, Postoperatively Day 1, 1 week, 3 months and 6 months

Secondary

MeasureTime frame
Diplopia Enopthalmos Globe Position Ocular Motility Vision Eye Movement Restriction Timepoint: Preoperatively, Postoperatively Day 1, 1 week, 3 months & 6 months

Countries

India

Contacts

Public ContactHarshit Singh

CDER, AIIMS, NEW DELHI

bhatt_krushna@yahoo.com9899325168

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026