| CTRI Number |
CTRI/2023/10/059100 [Registered on: 25/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFICACY OF BLONKING IN COMPUTER VISION SYNDROME |
|
Scientific Title of Study
|
EFFICACY OF A RANDOMIZED TRIAL TO OPTIMIZE BLINKING ON VISION IN COMPUTER VISION SYNDROME. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul Sadhwani |
| Designation |
Post Graguate Student |
| Affiliation |
Kalinga institute of medical sciences , Patia, Bhubaneswar |
| Address |
OPD NO 42, GROUND FLOOR
DEPARTMENT OF OPHTHALMOLOGY KIMS , BHUBANESWAR , PATIA , ODISHA
Khordha
ORISSA
751024
India |
| Phone |
9340300039 |
| Fax |
|
| Email |
parulsadhwani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SOUMYA KANTA MOHANTY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Kalinga institute of medical sciences , Patia, Bhubaneswar |
| Address |
ROOM NO 42 , DEPARTMENT OF OPHTHALMOLOGY , KIMS , BHUBANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9340300039 |
| Fax |
|
| Email |
soumya.mohanty@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SOUMYA KANTA MOHANTY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Kalinga institute of medical sciences , Patia, Bhubaneswar |
| Address |
ROOM NO 42 , DEPT OF OPHTHALMOLOGY , KIMS , PATIA , BHUBANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9340300039 |
| Fax |
|
| Email |
soumya.mohanty@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| rROOM NO 42, GROUND FLOOR , DEPARTMENT OF OPHTHALMOLOGY , KIMS , PATIA , BHUBANESWAR |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| PARUL SADHWANI |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
KIMS HOSPITAL OPHTHALMOLOGY DEPARTMENT ROOM NO 42
KIIT UNIVERSITY CAMPUS 5
PATIA
BHUBANESWAR ODISHA 751024
Khordha
ORISSA |
9340300039
parulsadhwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H527||Unspecified disorder of refraction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OPTIMIZATION OF BLINKING IN PATIENTS OF COMPUTER VISION SYNDROME TAKEN AS CASES |
PATIENTS OF COMPUTER VISION SYNDROME DIVIDED IN TWO GROUPS AS CASES AND CONTROLS WHERE IN CASES OPTIMIZATION OF BLINKING GIVEN ALONG WITH STANDARD
TREATMENT OF COMPUTER VISION SYNDROME FOR 6 MONTHS |
| Comparator Agent |
PATIENTS OF COMPUTER VISION SYNDROME TAKEN AS CONTROLS |
CONTROLS GIVEN STANDARD TREATMENT OF COMPUTER VISION SYNDROME ONLY FOR 6 MOINTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 All diagnosed cases of CVS
2 Age group 18 to 40 years
3 Patients with CVS with or without mild to moderate refractive error
4 Subjects giving written informed consent for the study
|
|
| ExclusionCriteria |
| Details |
1. Non-consenting , uncooperative and hostile patient
2. Patients having other ocular diseases causing dry eyes-
Ocular surface disorders
Allergic conjunctivitis
3. Patients having systemic illnesses causing like-
Uncontrolled Diabetes
Uncontrolled Thyroid disease
Secondary Sjogren’s syndrome
4. Patient using any ocular medication causing dry eyes.
5. Patient having any past history of any ocular surgery.
6. Patients using contact lenses.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the difference in visual acuity, refractive power and orthoptic parameters before and after blinking exercises |
30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To monitor the qualitative improvement in asthenopic symptoms.
2. To assess the tear film parameters and ocular surface changes pre and post blinking exercises
|
30 min |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
Modification(s)
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/11/2023 |
| 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="2"
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
|
Computer vision syndrome also referred to as digital eye strain, describes a group of eye and vision-related problems that result from prolonged computer, tablet, e-reader, and cell phone use.
It is suggested that 64-90% of computer users experience visual symptoms that may include eyestrain, headaches, ocular discomfort, dry eye, diplopia, and blurred vision either at near or when looking into the distance after prolonged computer use. Reports have noted a strong association between dry eye and CVS, with longer periods of computer work being associated with a higher prevalence of dry eye. Dry eye during computer operation could be caused by either a reduced spontaneous blink rate, increased corneal exposure and poor environmental conditions. Over a period of time, the dry eye leads to higher blink rates with incomplete blinking due to increased tear film instability. The instability of the precorneal tear film affects the interval between the blinks with alternating interblink periods of longer and shorter duration . This vicious cycle of altered blinking rate with component of incomplete blinking and variable interblink intervals disturbs the work efficiency and the dry eyes among computer users and also has become an important public health problem. In this study we are trying to compare two groups in which one who gets optimized blinking and the other with a standard treatment to observe the effectiveness of optimized blinking in cases of computer vision syndrome. |