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

Phase 4

Completed

• Conditions: Health Condition 1: H479- Unspecified disorder of visual pathways

• Registration Number: CTRI/2020/01/022683
• Lead Sponsor: Department of Oral and Maxillofacial Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-20
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

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

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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