| CTRI Number |
CTRI/2024/07/071173 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of hydroxychloroquine dosage on visual function in individuals with rheumatoid arthritis |
|
Scientific Title of Study
|
Association of hydroxychloroquine dosage on visual function among individuals with rheumatoid arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thondavada Lalitha |
| Designation |
Master of Optometry 1st year |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry,
Manipal College of Health Professions,
Manipal Academy of Higher Education,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9701992979 |
| Fax |
|
| Email |
thondavada.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Preethi Naik |
| Designation |
Assistant professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry,
Manipal College of Health Professions,
Manipal Academy of Higher Education,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105619834 |
| Fax |
|
| Email |
preethi.naik@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Thondavada Lalitha |
| Designation |
Master of Optometry 1st year |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry,
Manipal College of Health Professions,
Manipal Academy of Higher Education,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9701992979 |
| Fax |
|
| Email |
thondavada.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Optometry,
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Thondavada Lalitha |
| Address |
Department of Optometry,
Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104
|
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Thondavada Lalitha |
KASTURBA HOSPITAL |
Department of Ophthalmology and Department of Medicine,
Kasturba Hospital,
Manipal,
India
576104
Udupi
KARNATAKA |
9701992979
thondavada.mchpmpl2023@learner.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 (student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H538||Other visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group >18 years old
2.Both males and females
3.Individuals diagnosed with rheumatoid arthritis under hydroxychloroquine dosage |
|
| ExclusionCriteria |
| Details |
1.Any systemic disease other than rheumatoid arthritis
2.History of contact lens usage & computer use of more than 6 hours
3.Patients with a history of ocular injury or intra-ocular surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual acuity,
contrast sensitivity,
color vision,
stereo acuity,
photo stress test |
One time measurement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Tear film quality , Intraocular pressure and
Structural changes |
One time measurement |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
29/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a prospective observational, single center study, Association of hydroxychloroquine dosage on visual function among individuals with rheumatoid arthritis in 80 patients that will be conducted in department of Ophthalmology and Medicine, Kasturba Hospital, Manipal, India. Primary outcome will be visual function among individuals with rheumatoid arthritis. Secondary outcome will be the administration of year film quantity and intra ocular pressure among individuals with rheumatoid arthritis. |