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Study to Evaluate damage to the Optic Nerve and Vision occurring due to Fractures of the Head and eye bones.

Evaluation of Incidence of Traumatic Optic Neuropathy with Orbital Wall Involvement in Craniofacial Fractures- A Prospective Observational Study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/01/022683
Enrollment
50
Registered
2020-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H479- Unspecified disorder of visual pathways

Interventions

Intervention1: Nil: Nil Control Intervention1: nil: nil

Sponsors

Department of Oral and Maxillofacial Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All subjects with head injuries & facial fractures presenting within 1 week of history of Trauma, with any of the following: 1. Post-traumatic decreased visual acuity 2. Defective colour vision 3. RAPD (Relative afferent pupillary defect) 4. Visual field defects 5. Subnormal VEP (visually evoked potential) 6. CT scan showing fracture of optic canal or any bony fragments compressing optic nerve or presence of haemorrhage in nerve sheath.

Exclusion criteria

Exclusion criteria: 1) Subjects presenting later than 1 week of the incidence of trauma. 2) Subjects with penetrating or open globe injuries 3) Subjects with pre-existing optic nerve disease (known cases of glaucoma, multiple sclerosis, giant cell arthritis, intra-orbital tumors) 4) Subjects with pre-existing ocular disease with hazy media which hampers fundus examination. 5) Subjects on drugs known to cause optic neuropathy (anti-TB drugs)

Design outcomes

Primary

MeasureTime frame
To evaluate the incidence of traumatic optic neuropathy in subjects with orbital wall involvement in craniofacial fractures without head injury.Timepoint: At the time of Presentation

Secondary

MeasureTime frame
To evaluate the diagnostic parameters which aid the diagnosis of Traumatic optic neuropathy.Timepoint: At the time of Presentation;To evaluate the patterns of craniofacial fractures which were associated with Traumatic optic neuropathy.Timepoint: At the time of Presentation;To monitor the Progress of Traumatic Optic Neuropathy in observational and conservative management.Timepoint: At 3, 5, 7 and 15 days

Countries

India

Contacts

Public ContactDr Srivalli Natarajan

Mahatma Gandhi Missions Dental College and Hospital, Navi Mumbai

srivallis@hotmail.com9769088803

Outcome results

None listed

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