| CTRI Number |
CTRI/2019/08/020537 [Registered on: 05/08/2019] Trial Registered Prospectively |
| Last Modified On: |
02/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Light (Color temperature, CRI)] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
comparison of changes in lens inside the eye and color seen by the eye under various lighting conditions |
|
Scientific Title of Study
|
COMPARISON OF ACCOMMODATION AND COLOR VISION AT VARIOUS LEVELS OF LED CORRELATED COLOR TEMPERATURES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Binu Sudheer |
| Designation |
Master Student |
| Affiliation |
Manipal Academy of Higher Education (MAHE) |
| Address |
M.Optometry, 2nd year, 3rd semester (Roll No:181141001),Department of Optometry, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal
Manipal Academy of Higher Education (MAHE),Manipal,Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8217044248 |
| Fax |
|
| Email |
binusudheer2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh KR |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education (MAHE), Manipal |
| Address |
Assistant Professor
Department of Electrical and Electronics
Manipal Institute of Technology
MAHE,Manipal
Manipal Academy of Higher Education(MAHE),Manipal,Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8050112974 |
| Fax |
|
| Email |
shailesh.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Radhika |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education(MAHE) |
| Address |
Assistant Professor
Department of Optometry
MAHE,Manipal
Manipal Academy of Higher Education(MAHE),Manipal,Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8217044248 |
| Fax |
|
| Email |
radhika.pu@mnaipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Optometry (MCHP),Manipal Academy of Higher Education,Manipal,Karnataka-576104 |
| Department of Electricals and Electronics (MIT),Manipal Academy of Higher Education,Manipal,Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Binu Sudheer |
| Address |
7-1-D1 Anupama House Vittalwadi, Parkala,Udupi Taluk and District-576107, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Radhika RP |
Manipal College of Health Science |
Preclinical Lab (Store room),Department of Optometry,3rd Floor,Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE),Manipal-576104, Udupi Taluk and District,Karnataka
Udupi
KARNATAKA |
8277412069
radhika.pu@manipal.edu |
| Dr Shailesh KR |
Manipal Institute of Technology |
Ground floor, Electrical and Electronics Department,Manipal Institute Technology (MIT), Manipal Academy of Higher Education (MAHE),Manipal-576104, Udupi Taluk and District,Karnataka
Udupi
KARNATAKA |
8050112974
shailesh.kr@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committiee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ocular accomodation,Color vision, Pupil size.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Light |
Sunlight(Color temperature range-2700 to 6500Kelvin) |
| Intervention |
Light (Color Temperature(Color) and Lux Level (Brightness)) Tunable |
YEE (Light) Tunable (Xiaomi Company). Model No: YLDP05YL. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 35 years
2. Not on any medications
3. No diplopia reported during the ocular motility test
4. Near point of convergence (RAF rule) ≤ 10cm
5. Amplitude of accommodation (push up RAF rule) normal for age (greater than 10D)
6. Stereo acuity (Titmus circles) of < 80 seconds of arc
7. Normal red/green colour vision (Ishihara)
8. Astigmatism of < 0.75DC
9. Visual acuity of at least 6/6 in each eye
10. Cover test of < 5Δ horizontal phoria and < 0.5Δ vertical phoria
|
|
| ExclusionCriteria |
| Details |
• Any known ocular pathology
• Binocular vision anomalies
• Systemic diseases affecting vision
• Any colour vision defects
• Migraine or history of migraine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accommodation-Dioptre, Time-Seconds,Color vision-Errors (number),Color Temperature-Kelvin |
5 minutes after adaptation to light (Accommodation measurement), next intervals (1 minute accommodation relaxation time is given), then continued on between each intervals for accommodation. For color vision only adaptation time and no accommodation relaxation time.Total timing of 2 hours per subject. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pupil size-Millimeter,CRI-Color Rendering Index |
Pupil size measurement is taken which is done immediately after 5 minutes adaptation time, CRI and color temperature is interrelated and is measured during the lighting setup. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
12/08/2019 |
| Date of Study Completion (India) |
27/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/11/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Testing of accommodation under various colour temperatures gives an idea about the reason behind the accommodation variation, setting up lighting Standards for a clinic , Pupil size change can be related to accommodation, Tunable LED light can be used for colour vision testing and for low vision patient (since it is color temperature tunable). (CCT-Correlated Color Temperature) Accommodation- MEM Retinoscopy (Monocular estimation method), Negative relative accommodation and Positive relative accommodation, Minus lens method and pupil size is measured by Plus Optix Paediatric Autorefractometer. Color vision in Farnsworth D15 and Ishihara plates. Adaptation Time- 5 Minutes , Lux level of 270 lux for farnsworth D15 test, Accommodation testing of 430 lux. Only CCTs which has highest CRI (Color Rendering Index) is selected for color vision testing and changes in accommodation is seen with respect to CRI ,SPD and CCT. Here under each 6 lighting conditions, pupil size and accommodative response was measured. Then the other factors like Negative relative accommodation(NRA), Positive relative accommodation(PRA), Minus lens method was measured to prevent visual fatigue. Then at higher CRI (93,93,94) lightings of 5500K, 6500K and 8000K, the color vision testing was done. These were then analyzed using Repeated measures of ANOVA and Pair t test. Then the accommodation and pupil size change was compared with that of under natural light. The natural light measurement was done at MIT ground(Latitude-13.343581,
Longitude- 74.794044) . This then gives idea about the change in accommodative response. Hypothesis testing: a. Null hypothesis: There is no change in accommodation and color vision with respect to CCT variation b. Alternate Hypothesis: There is a change in accommodation and color vision with respect to CCT variation |