| CTRI Number |
CTRI/2025/05/086737 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on People with Eye Injuries Sent for Glaucoma Treatment at a South Indian Eye Hospital |
|
Scientific Title of Study
|
An Analysis of Demographic Profile, Risk Factors and Clinical Course of Patients referred to Glaucoma Services Following Ocular Trauma at a Tertiary Eye Hospital in South India |
| 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 Sanjana Ahuja |
| Designation |
Postgraduate Resident, DNB |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room No. 21, 1st floor, Glaucoma Department,Aravind Eye Hospital , Thavalakuppam, Cuddalore Main Road
Pondicherry
PONDICHERRY
605007
India |
| Phone |
7974761119 |
| Fax |
|
| Email |
sanjana_ahuja21@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Upadhyaya |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room No. 21, 1st floor, Glaucoma Department,Aravind Eye Hospital , Thavalakuppam, Cuddalore Main Road
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Upadhyaya |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Aravind Eye Hospital , Thavalakuppam, Cuddalore Main Road
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Pondicherry, Thavalakuppam, Cuddalore Main Road, India 605007 |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital Pondicherry |
| Address |
Room No. 21, 1st Floor, Glaucoma Department, Aravind Eye Hospital, Pondicherry, Thavalakuppam, Cuddalore Main Road, India 605007 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sanjana Ahuja |
Aravind Eye Hospital ,Pondicherry |
Room no. 21, 1st floor, Glaucoma Department Aravind Eye Hospital ,Pondicherry, Thavalakuppam, Cuddalore Main Road , India 605007
Pondicherry
PONDICHERRY |
7974761119
sanjana_ahuja21@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry |
Approved |
| Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H403||Glaucoma secondary to eye trauma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with a documented history of ocular trauma
2. Patients referred to glaucoma services for Evaluation following Ocular Trauma or with IOP more than 21mmHg or has characteristic disc or field changes or patients with gonioscopic abnormalities post trauma
|
|
| ExclusionCriteria |
| Details |
1. Pre-existing glaucoma or ocular hypertension.
2. Systemic conditions affecting IOP
3 Patients with Cognitive Impairment
4 Children with intellectual developmental disorders or children with special needs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical course and management outcomes of patients referred to Glaucoma Services following ocular trauma, assessed by intraocular pressure (IOP) control , changes at Optic Disc or Gonioscopy changes |
Follow up at 10 days, 1 month, 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Prevalence and distribution of different mechanisms leading to post-traumatic ocular hypertension or glaucoma.
2. Impact of socioeconomic factors, referral patterns, and time from trauma to glaucoma service presentation on short-term treatment outcomes. |
Follow up at 10 days, 1 month, 3 months. |
|
|
Target Sample Size
|
Total Sample Size="202"
Sample Size from India="202"
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)
|
20/05/2025 |
| 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 Yet Recruiting |
| 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
|
This is a prospective cohort study aimed at analyzing the demographic profile, risk factors, clinical presentation, and short-term outcomes of patients referred to glaucoma services following ocular trauma at a tertiary eye hospital in South India. The study will include patients aged above 5 years with a history of ocular trauma and elevated intraocular pressure (IOP) or signs of glaucoma. A minimum of 202 eyes will be enrolled. Detailed ophthalmic evaluations will be conducted at baseline, 10 days, 1 month, and 3 months, including IOP measurements, gonioscopy, fundus examination, and visual field analysis. The study aims to assess the prevalence and mechanisms of post-traumatic ocular hypertension or glaucoma and evaluate the influence of socioeconomic factors, referral patterns, and time to presentation on treatment outcomes. Ethical approval has been obtained, and the study is classified as minor increase over minimal risk as per ICMR guidelines. |