| CTRI Number |
CTRI/2023/08/056366 [Registered on: 10/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of accommodation and vergence in different types of myopia |
|
Scientific Title of Study
|
Comparison of accommodation and vergence parameters in early and late-onset myopia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shravya |
| Designation |
Student pursuing Master of Optometry |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8495826165 |
| Fax |
|
| Email |
shravya.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Salai Dhavamathi J |
| Designation |
Assistant Professor- Senior scale |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9176654452 |
| Fax |
|
| Email |
dhavamathi.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shravya |
| Designation |
Student pursuing Master of Optometry |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8495826165 |
| Fax |
|
| Email |
shravya.mchpmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal- 576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Shravya |
| Address |
Department of Optometry, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal. |
| 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 |
| Ms Shravya |
Kasturba Hospital |
Department of Ophthalmology, 2nd Floor, Room no 25.
Udupi
KARNATAKA |
8495826165
shravya.mchpmpl2022@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: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Early and late-onset myopes
Early onset myopes: Individuals who had their first glass or contact lens prescription before the age of 15 years.
Late onset myopes: Individuals who had their first glass or contact lens prescription at 15 year of age or older.
Mild to moderate myopia (-0.50D to -6.00D)
Astigmatism ≤1.50 D
|
|
| ExclusionCriteria |
| Details |
High myopia (> -6.00 D)
Astigmatism > -1.50 D
Subjects already diagnosed with binocular vision anomalies
Anisometropia
Strabismus
Other ocular anomalies
Individuals using medication that effect accommodation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Accommodation: Accommodation amplitude, accommodative facility, accommodative response
Vergence: Near point of convergence, vergence facility, positive & negative fusional vergence
|
All the outcomes will be measured on the same day (There is no follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/08/2023 |
| 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 study will begin after obtaining the approval from Institutional Research Committee, MCHP and Institutional Ethics Committee, KH, Manipal. Registration will be done in Clinical Trial Registry- India. Subject recruitment will be done from Ophthalmology department, KMC, Manipal, Wellness clinic, MIT, Manipal and also through advertisement. Subjects will be screened and assessed for eligibility criteria. Consent will be obtained from the study participants. In this study subjects with mild to moderate myopia aged between 18-35 years will be categorized into two groups: Early-onset myopia (who had their first prescription before 15 years of age) and late-onset myopia (who had their first prescription at the age of 15 years or older). The participants who are diagnosed with squint, anisometropia along with any ocular disorders will be excluded after comprehensive eye examination. Study duration will be 60 minutes. All the participants will undergo routine eye examination which includes visual acuity testing, subjective and objective refraction and slit lamp examination. Accommodation and Vergence parameters such as accommodation amplitude (AA), AC/A ratio, facility of accommodation (AF), accommodative response, convergence response (NPC), positive and negative fusional vergence (PFV and NFV) and vergence facility (VF) will be measured. NPA: Near point of accommodation will be measured using standard push up technique using RAF ruler. Accommodative facility: It will be measured using accommodative flipper. Accommodative response (MEM retinoscopy): MEM retinoscopy will be performed using streak retinoscope to determine the lead or lag of accommodation. NPC: It will be measured by standard push up technique using RAF ruler. NFV: It will be measured using prism bar (Base in). PFV: PFV will be measured using prism bar ((Base out). Vergence facility: It will be measured using vergence flipper. AC/A ratio: It will be calculated using gradient method. |