| CTRI Number |
CTRI/2023/09/057454 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
11/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of movable perimetry with non-movable perimetry among subjects with or without any eye disease |
|
Scientific Title of Study
|
Comparison of Portable Perimetry with Standard Automated Perimetry among subjects with and without any ocular disease |
| 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 Ramesh S Ve |
| Designation |
Professor, Department of Optometry |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry,3rd floor Room No 313 Manipal College of Health Professions
Udupi
KARNATAKA
576104
India |
| Phone |
8861330950 |
| Fax |
|
| Email |
ramesh.sve@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Deeksha Nayak |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry, 3rd floor Room No 313, Manipal College of Health Professions
Udupi
KARNATAKA
576104
India |
| Phone |
8088620223 |
| Fax |
|
| Email |
deeksha2.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neetha KIR |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Ophthalmology,2nd floor, Room No 25,Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886161979 |
| Fax |
|
| Email |
neetha.kir@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions (MCHP),Manipal Academy of Higher Education (MAHE),Manipal-576104,Karnatka,India |
|
|
Primary Sponsor
|
| Name |
Dr Ramesh S Ve |
| Address |
Department of Optometry, 3rd floor,Room No- 313,Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal-576104,Karnataka,India |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
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 Ramesh S Ve |
Kasturba Hospital |
Department of Opthalmology,2nd floor,
Consultation room no 26
Udupi
KARNATAKA
Udupi
KARNATAKA |
8861330950
ramesh.sve@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H408||Other glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Cases
Eye with worse visual field defect
Early to advanced glaucoma (cupping of optic nerve damage, SAP reports indicating visual field defects
Pseudophakic after 1 month
Retinal diseases include Retinopathy, Retinitis Pigmentosa, ARMD, Vascular retinopathy etc.
Normal
Aged between 18 - 85 years
Diagnosed healthy eyes
Best Corrected Visual Acuity (BCVA) of 0.1 log MAR or better
The refractive error between ±6.00 DS equivalent & cylindrical correction within ± 3.00 DC
|
|
| ExclusionCriteria |
| Details |
Cases
Visually significant cataract (based on lens opacities classification)
Recent cataract surgery (1 month)
History of retinal surgery
Unable to perform perimetry
Visual acuity less than 6/60
Corneal dystrophy, trauma
History of having epilepsy or any other neurological disorders
Normal
Any ocular pathology other than cataract
Systemic diseases affecting visual function
Under any medication that affects vision
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reliability indices, Global indices and individual sensitivity, threshold values and variability. |
Reliability indices, Global indices and individual sensitivity, threshold values and variability at Baseline (15-20 minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="245"
Sample Size from India="245"
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)
|
21/09/2023 |
| 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="0"
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
|
The research will be initiated after the approval from the Institution Research Committee (IRC) following the Institutional Ethics Committee (IEC) and then approval from the university. The participants will be recruited & written informed consent will be taken. They will then undergo routine eye examination (if they didn’t have any past one month) with the standard or the widely used measure for the detailed history taking, vision assessment, refraction, extraocular motility test, intraocular pressure measurement, anterior segment examination, posterior segment examination. An additional set of standard tests required to confirm the eligibility criteria for the normal subjects (if they didn’t have any past 1 month) is perimetry and for glaucoma & retinal subjects (if they didn’t have any past 1 month) are perimetry. After this set of procedures, those who are fulfilling the eligibility criteria will be given an appointment based on his/her and the examiner’s feasibility. In Phase I and Phase II, the patients will be recruited from the eye OPD only. Controls are the participants who will have no clinically significant retinal conditions like Glaucoma and Vascular retinopathies. Mainly patients who will be coming for the general eye examination for glasses one month after the cataract surgery will be included in the study. |