| CTRI Number |
CTRI/2019/11/021938 [Registered on: 08/11/2019] Trial Registered Prospectively |
| Last Modified On: |
05/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to compare the pressure in eye before and after refractive surgery in Indian myopic eyes. |
|
Scientific Title of Study
|
A clinical study to correlate the pre and post operative intraocular pressure status in post FEMTOLASIK LASIK and Small Incision Lenticule Extraction in Indian myopic eyes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHIVA KUSHWAH |
| Designation |
SECONDARY DNB RESIDENT |
| Affiliation |
Centre For Sight |
| Address |
EXPRESS OPD DEPARTMENT OF CATARACT & REFRACTIVE SURGERY
OPHTHALMOLOGY CENTRE FOR SIGHT HOSPITAL B 5/24 SAFDARJUNG ENCLAVE NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
8989271707 |
| Fax |
|
| Email |
shivakushwah22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAJ GEN J K S PARIHAR |
| Designation |
MS DOMS DNB FAMS |
| Affiliation |
Centre For Sight |
| Address |
CENTRE FOR SIGHT B 5/24 SAFDARJUNG ENCLAVE New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9818992191 |
| Fax |
|
| Email |
jksparihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHIVA KUSHWAH |
| Designation |
SECONDARY DNB RESIDENT |
| Affiliation |
Centre For Sight |
| Address |
EXPRESS OPD DEPARTMENT OF CATARACT & REFRACTIVE SURGERY CENTRE FOR SIGHT B 5/24 SAFDARJUNG ENCLAVE NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
8989271707 |
| Fax |
|
| Email |
shivakushwah22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre For Sight B5/24 Safdarjung Enclave New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Shiva Kushwah |
| Address |
Centre For Sight Safdarjung Enclave New Delhi 110029 |
| Type of Sponsor |
Other [self] |
|
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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 Shiva Kushwah |
Centre For Sight |
Express OPD Department of Cataract & Refractive Surgery Centre For Sight Hospital B 5/24 Safdarjung Enclave New Delhi 110029
New Delhi
DELHI |
8989271707
shivakushwah22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRE FOR SIGHT INSTITUTIONAL MEDICAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
age group between 20 to 30 years
Both sex
Clear cornea
Astigmatism less than 1D
Myopia of 2D to 5D
Refraction stable for past 1 years(+/- 0.5Diopter)
Indian ethnicity
Central corneal thickness 520 to 550µm
|
|
| ExclusionCriteria |
| Details |
Age less than 20 years or more than 30 years
Any history of systemic illness like Diabetes, Hypertension, Asthma, collagen vascular disease, pregnancy ocular injuries.
Family history of glaucoma
Hypermetropia
Astigmatism more than 1D
Myopic less than 2D or more than 5D
Corneal pathology such as scarring & keratoconus
Patients with history of any previous ocular surgery.
Ethnicity other than Indian.
Central corneal thickness less than 520 µm or more than 550µm
Steroid responders.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the pre & post intraocular pressure status following Small incision lenticule extraction FEMTOLASIK & LASIK in presence of altered corneal thickness and biomechanics in Indian myopic eye.
|
1 week 4 week 8 week 12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish a nomogram to correlate between apparent & real intraocular pressure using CORVIS ST NONCONTACT TONOMETER APPLANATION TONOMETER & to use most suitable method to evaluate intraocular pressure in post refractive eyes |
1 year |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
09/11/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study to assess the pre & post intraocular pressure(IOP) status following Small Inscision Lenticule Extraction Femtolasik & Lasik in the presence of altered corneal thickness & biomechanics in Indian myopic eyes and also to establish a nomogram to correlate between the apparent & real IOP using CORVIS ST NON CONTACT TONOMETER & APPLANATION TONOMETER & to to use the most suitable method to evaluate IOP in post refractive eyes . All myopic patients fulfilling the inclusion crietaria will be registered for the study & IOP will be measured before the surgery then after surgery at 1 weeks 4 weeks 8 weeks & 12 weeks.Statistical analysis will be performed by using descriptive
and inferential statistics using chi square test/fisher exact test for
categorical data. Independent sample t-test to compare
mean values between the two groups and ANOVA followed by post-hoc test will be
used to compare mean values between more than two groups.Paired t-test will be used to see the
relative change with respect to time. Any other test if applicable at the time of analysis will be used. P-value less than 0.05 considered as significant at
95% confidence level. The statistical software SPSS version
24.0 or higher will be used in the analysis. Primary outcome can be seen at 3 months of each participant enrolled and nomogram will be prepared at one year of study.
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