| CTRI Number |
CTRI/2025/08/092602 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Eye health in people with orbital floor fractures managed without surgery |
|
Scientific Title of Study
|
Ocular outcomes in patients with orbital fracture involving the orbital floor that did not undergo orbital floor repair |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manali Hazaraika |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Ophthalmology, 2nd floor, OPD block, Kasturba Hospital, Manipal, Udupi District Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7358897496 |
| Fax |
|
| Email |
manali.hazarika@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Shrestha Shah |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Ophthalmology, 2nd floor, OPD block, Kasturba Hospital, Manipal, Udupi District Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7358897496 |
| Fax |
|
| Email |
shahshrestha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manali Hazaraika |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Ophthalmology, 2nd floor, OPD block, Kasturba Hospital, Manipal, Udupi District Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7358897496 |
| Fax |
|
| Email |
manali.hazarika@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology, Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Department of Ophthalmology |
| Address |
Department of Ophthalmology, 2nd floor OPD block, Kasturba Hospital, Manipal, Udupi, Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manali Hazaraika |
Kasturba Hospital, Manipal |
Department of Ophthalmology, 2nd floor, OPD block, Kasturba Hospital, Manipal, Udupi District Karnataka- 576104
Udupi
KARNATAKA |
07358897496
manali.hazarika@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S023||Fracture of orbital floor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with CT proven orbital floor fractures in KH, Manipal
2. Patients who did not undergo orbital floor repair for orbital floor fracture from January 2020 to November, 2025
3. patients who did not under orbital floor repair for orbital floor fracture but underwent zygomatico- maxillary complex fracture repair from January 2020 to November, 2025
|
|
| ExclusionCriteria |
| Details |
Patients for whom data on first visit or follow up data is not available |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess globe position, restriction of ocular movements and diplopia in patients who did not undergo orbital floor repair at the time of first presentation in ophthalmology OPD and on follow up |
1. To assess globe position, restriction of ocular movements and diplopia in patients who did not undergo orbital floor repair at the time of first presentation in ophthalmology OPD and on 1st follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess vision, intraocular pressure (IOP) and extra ocular movements in patients who did not undergo orbital floor repair at the time of first presentation in ophthalmology OPD and on follow up
2.To observe variation in outcomes based on the type of orbital floor fracture determined by CT scan
|
vision, intraocular pressure (IOP), extra ocular movements and variation in outcomes based on the type of orbital floor fracture determined by CT scan at the time of first presentation in ophthalmology OPD and on 1st follow up |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Permission to
access the records in the medical records department will be taken from The
Medical Superintendent. We will retrospectively review the medical records of
patients with orbital fracture who did not undergo surgical intervention
The data of vision, IOP, extra ocular movements,
diplopia, globe position of the patient on their first visit to ophthalmology
OPD after the accident and on their follow up will be assessed. Type of
fracture will be determined with the help of CT.
The
ocular outcomes of patients with orbital fracture who did not undergo surgical intervention will be analyzed |