| CTRI Number |
CTRI/2008/091/000121 [Registered on: 04/08/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Other |
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Public Title of Study
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FIXATION PREFERENCE TO ASSESS VISION OF STRABISMIC CHILDREN. |
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Scientific Title of Study
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Evaluation of CSM (Central, Steady, Maintained) fixation Grading for Predicting Inter-eye Visual Acuity Difference to Diagnose and Treat Amblyopia in Strabismic Patients. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
DR MIHIR KOTHARI |
| Designation |
|
| Affiliation |
|
| Address |
JYOTIRMAY EYE CLINIC, 205 GANATRA ESTATE,
KHOPAT
Thane
MAHARASHTRA
400601
India |
| Phone |
91-22-25067173 |
| Fax |
|
| Email |
drmihirkothari@jyotirmay.com |
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Details of Contact Person
Scientific Query
|
| Name |
DR MIHIR KOTHARI |
| Designation |
|
| Affiliation |
|
| Address |
JYOTIRMAY EYE CLINIC, 205 GANATRA ESTATE,
KHOPAT
Thane
MAHARASHTRA
400601
India |
| Phone |
91-22-25067173 |
| Fax |
|
| Email |
drmihirkothari@jyotirmay.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MIHIR KOTHARI |
| Designation |
|
| Affiliation |
|
| Address |
JYOTIRMAY EYE CLINIC, 205 GANATRA ESTATE,
KHOPAT
Thane
MAHARASHTRA
400601
India |
| Phone |
91-22-25067173 |
| Fax |
|
| Email |
drmihirkothari@jyotirmay.com |
|
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
NIL |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MIHIR KOTHARI |
JYOTIRMAY EYE CLINIC |
205 GANATRA ESTATE,KHOPAT-400601
Thane
MAHARASHTRA |
91-22-25478081
DRMIHIRKOTHARI@JYOTIRMAY.COM |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIL (THIS STUDY IS DONE BY A CLINICIAN SOLO PRIVATE PRACTICE) IT FOLLOWS THE CRITERIA OF DECLARATION OF HELSINIKI |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
AMBLYOPIA, SQUINT, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
NIL |
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| Comparator Agent |
NIL |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
|
| Details |
CHILDREN AGED 5-16 YEARS, with manifest, horizontal, comitant deviation more than 10PD |
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| ExclusionCriteria |
| Details |
PREVIOUSLY OPERATED FOR SQUINT, NYSTAGMUS, OTHER OCLUAR COMORBIDITY, BCVA IN BETTER EYE <6/9 |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Other |
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Blinding/Masking
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Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| INTER EYE VISUAL ACUITY DIFFERENCE |
IMMEDIATE (CROSS SECTION STUDY) |
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Secondary Outcome
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Target Sample Size
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Total Sample Size="100"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This prospective masked observational cohort study would be performed in the department of Pediatric Ophthalmology and Strabismus of a tertiary teaching eye hospital. An optometrist would record the best-corrected distance visual acuity on a 6 meter Snellen?s chart. A masked, fellowship trained, Pediatric Ophthalmologist would then perform a detailed ophthalmic examination including the evaluation of the fixation behavior.
The fixation behavior would be evaluated by having the patient fixate on an accommodative target held at 40cm and with best correction in place. The fixation would be graded as central, steady and maintained CSM), unmaintained (CSUM) or central, unsteady, unmaintained (CUSUM) or as uncentral, unsteady and unmaintained (UCUSUM) or wandering fixation. Amblyopia would be defined as the inter-eye acuity difference of > 0.2 LogMAR.
Snellen Acuity would be converted to the LogMAR value and range of visual acuity, median visual acuity and standard deviation for each grade of fixation would be calculated. Sensitivity, specificity and predictive values for the diagnosis of amblyopia using CSM grading would be calculated from the Bayesian tables. Two-tailed Student?s t-test would be used to determine the statistical significance.
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