| CTRI Number |
CTRI/2025/09/094092 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
It is a clinical trial to measure the efficacy and safety of SMILE( Small Incision Lenticule Extraction) surgery across different grades of myopia |
|
Scientific Title of Study
|
Comparison of visual and refractive outcomes of Small Incision Lenticule Extraction in mild – moderate vs high 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 |
Dr Parul Jain |
| Designation |
Professor |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of Ophthalmology, Maulana Azad Medical College, Guru Nanak Eye Centre, New Delhi
Central
DELHI
110002
India |
| Phone |
9971927902 |
| Fax |
|
| Email |
pjain811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kapil Chalana |
| Designation |
Post graduate |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of Ophthalmology, Maulana Azad Medical College, Guru Nanak Eye Centre,New Delhi
Central
DELHI
110002
India |
| Phone |
9871748272 |
| Fax |
|
| Email |
kapilchalana1998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kapil Chalana |
| Designation |
Post graduate |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of Ophthalmology, Maulana Azad Medical College, Guru Nanak Eye Centre,New Delhi
Central
DELHI
110002
India |
| Phone |
9871748272 |
| Fax |
|
| Email |
kapilchalana1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology, Maulana Azad Medical College, Guru Nanak Eye Centre,New Delhi (110002), India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah zafar Marg, New Delhi ,110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Kapil Chalana |
Guru Nanak Eye Centre |
Department of Ophthalmology, Maulana Azad Medical College, Guru Nanak Eye Centre,New Delhi, 110002
Central
DELHI |
9871748272
kapilchalana1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H542||Low vision, both eyes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Small Incision Lenticule Extraction surgery |
VisuMax 800.
This is a laser based surgery done to correct myopia.
It will be done in both the groups greater than and less than 6 D myopia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Stable refraction for 1 year prior to surgery
Minimum preoperative corneal thickness of 480 microns
Predicted residual stromal bed thickness morethan 280 microns
Patients wearing soft contact lenses will be instructed to stop wearing them for at least 1 week |
|
| ExclusionCriteria |
| Details |
Patients with history of trauma , prior ocular surgery or corneal scars
Keratoconus/ectatic corneal disorders
Pregnancy or Lactation
History of herpes keratitis
Uncontrolled Glaucoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportional change in uncorrected visual acuity(UCVA) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Proportional change in best corrected visual acuity(BCVA) at 3 months
2) Proportion of patients with Residual refractive error (spherical equivalent) at 3 months
3) Proportional change in Higher order aberrations of the total, anterior and posterior cornea surface at 6mm pupil size at 3 months(RMS, 3RD and 4th order HOA s)
4) Mean change in corneal densitometry of 0-2, 2-6 and 6-10mm concentric optical zones at 1 month and 3 months
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
20/09/2025 |
| 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
|
This is a Quasi Experimental study , comparing visual and refractive outcome of small incision lenticule extraction in mild- moderate vs high myopia , will be conducted in Guru nanak eye centre taking two groups less than 6 dioptre myopic patients greater than equal to 6 dioptre myopia patients. Primary objective- To evaluate of efficacy of SMILE procedure across different grades of myopia Secondary objective- To assess the safety of SMILE procedure across different grades of myopia we |