| CTRI Number |
CTRI/2024/11/076199 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational cross sectional study on prevalence of ocular surface disease in patients with Glaucoma on topical Anti Glaucoma medications |
|
Scientific Title of Study
|
Prevalence of Ocular surface Disease in patients with Glaucoma on topical Anti Glaucoma medications |
| 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. H Harshitha Yelamanchi |
| Designation |
Fellow in Glaucoma |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Glaucoma department.
Pedakakani,Guntur,
522509
ANDHRA PRADESH
522509
India |
| Phone |
06303972872 |
| Fax |
|
| Email |
drharshyelamanchi77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Malleswari Medikonda |
| Designation |
Senior consultant,Glaucoma department |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Glaucoma department.
Pedakakani,Guntur,
522509
ANDHRA PRADESH
522509
India |
| Phone |
9493714701 |
| Fax |
|
| Email |
malleswari6372@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. H Harshitha Yelamanchi |
| Designation |
Fellow in Glaucoma |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Glaucoma department.
Pedakakani,Guntur,
522509
ANDHRA PRADESH
522509
India |
| Phone |
6303972872 |
| Fax |
|
| Email |
drharshyelamanchi77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital
Glaucoma department.
Pedakakani,Guntur,Andhra Pradesh
522509
India |
|
|
Primary Sponsor
|
| Name |
Dr H Harshitha Yelamanchi |
| Address |
Sankara Eye Hospital
Glaucoma department.
Pedakakani,Guntur,
522509 |
| Type of Sponsor |
Other [] |
|
|
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 H Harshitha Yelamanchi |
Sankara Eye Hospital |
Glaucoma department.
Pedakakani,Guntur,
522509
Guntur
ANDHRA PRADESH |
6303972872
drharshyelamanchi77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara Eye Hospital Guntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Glaucoma and using topical medications for atleast 6 months |
|
| ExclusionCriteria |
| Details |
Patients on other topical drugs with preservatives
Current use of contact lenses.
Presence of Pterygium
Previous ocular surgeries
Recent clear corneal cataract surgery in last 3 months |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess Lipiview,Schirmers test,TBUT, and ocular surface grading |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="157"
Sample Size from India="157"
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)
|
05/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 STUDY IS OBSERVATIONAL CROSS SECTIONAL STUDY AIMED TO INVESTIGATE THE EFFECT OF TOPICAL GLAUCOMA MEDICATIONS ON LIPID LAYER THICKNESS AND MEIBOMIAN GLAND DYSFUNCTION USING LIPIVIEW INTERFEROMETER,TEAR FILM BREAK UP TIME,SCHIRMER TEST,CORNEAL AND CONJUNCTIVAL SCORES |