CTRI

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CTRI Number

CTRI/2025/08/092265 [Registered on: 04/08/2025] Trial Registered Prospectively

Last Modified On:

01/08/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

To compare the visual outcomes of two refractive surgery procedures Small Incision Lenticule Extraction and ICL in patients of moderate refractive error

Scientific Title of Study

To compare visual outcomes and patient satisfaction levels in patients undergoing implantable Collamer lens ICL implantation versus Small Incision Lenticule Extraction in cases of moderate myopia and myopic astigmatism

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
aloksati_123@rediffmail.com	ClinicalTrials.gov

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Supriya Dhar
Designation	Assoc Prof
Affiliation	Army Hospital RR Delhi Cantt
Address	Dept Of Ophthalmology Army Hospital RR Delhi Cantt South West DELHI 110010 India
Phone	8974795579
Fax
Email	supreme4995@live.com

Details of Contact Person
Scientific Query

Name	Supriya Dhar
Designation	Assoc Prof
Affiliation	Army Hospital RR Delhi Cantt
Address	Dept Of Ophthalmology Army Hospital RR Delhi Cantt DELHI 110010 India
Phone	8974795579
Fax
Email	supreme4995@live.com

Details of Contact Person
Public Query

Name	Supriya Dhar
Designation	Assoc Prof
Affiliation	Army Hospital RR Delhi Cantt
Address	Dept Of Ophthalmology Army Hospital RR Delhi Cantt DELHI 110010 India
Phone	8974795579
Fax
Email	supreme4995@live.com

Source of Monetary or Material Support

Dept Of Ophthalmology Army Hospital RR Delhi Cantt New Delhi-110010

NIL

Primary Sponsor

Name	Dr Supriya Dhar
Address	Dept Of Ophthalmology Army Hospital RR Delhi Cantt-10
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Supriya Dhar	Army Hospital RR Delhi Cantt	Dept Of Ophthalmology Army Hospital RR Delhi Cantt South West DELHI	8974795579 supreme4995@live.com
Supriya Dhar	New Delhi	Army Hospital RR Delhi Cantt South West DELHI	8974795579 supreme4995@live.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Army Hospital)R&R), Delhi Cantt	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	NIL

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Implantable Collamer Lens implantation	Implantable Collamer lens implantation will be carried out in the comparison arm of 50 eyes of 25 patients. The findings of vision and other related features between the intervention group and the comparator group will be compared along with assessing quality of life after surgery in a questionnaire form till 21 months after surgery
Intervention	Small Incision Lenticule Extraction SMILE	In 50 eyes of 25 Randomly allocated patients Small Incision Lenticule Extraction surgery will be carried out

Inclusion Criteria

Age From	21.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	Spherical equivalent of negative 3 to negative 6 Dioptres Refractive cylinder less than or equal to 2 Dioptres Best spectacle-corrected visual acuity of 20 by 40 or better A spherical or cylindrical error that has progressed at negative half Dioptres or less per year before the baseline measurement. The contact lens must have been removed at least two weeks before the baseline measurement. No evidence of irregular astigmatism on corneal topography Anterior chamber depth more than or equal to two point eight millimetre Corneal endothelial cell count more than or equal to two thousand cells per square millimetre

ExclusionCriteria

Details

Progressive or unstable myopia and astigmatism

Clinical or corneal topographic evidence of keratoconus

Residual recurrent or active ocular disease and retinal disease

Previous corneal surgery

Thinnest Pachymetry les than or equal to four hundred ninety micrometre

Residual Stromal Bed less than or equal to two hundred and eighty micrometre in patients undergoing Small Incision Lenticule extraction

Taking systemic medications and systemically immunocompromised or systemic diseases likely to affect wound healing such as diabetes connective tissue disease and severe atopy pregnant or nursing females.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1) Objectively measure pre- and post-operative higher-order ocular aberrations, including spherical aberration, vertical coma, trefoil, tetrafoil, and contrast sensitivity and subjectively use a quality of vision questionnaire to assess the same.	Day 01 01 week 01 month 03 months 06 months 12 months 18 months and 21 months

Secondary Outcome

Outcome	TimePoints
Assessment of Uncorrected and corrected visual acuity, efficacy and safety of the procedure, and endothelial cell count between two groups.	Day 01 01 week 01 months 03 months 06 months 12 months 18 months 21 months

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
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

Phase 2/ Phase 3

Date of First Enrollment (India)

12/08/2025

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

Over the past 20 years, refractive surgery has witnessed significant advancements, including Small Incision Lenticule Extraction (SMILE) and Implantable Collamer Lens (ICL). SMILE’s flapless design reduces postoperative dryness and offers biomechanical stability, making it a safe and effective option for patients with adequate corneal thickness and no irregularities. On the other hand, ICL is a minimally invasive procedure that implants a Collamer lens in phakic eyes, correcting a more comprehensive range of myopic correction (0 to -18.00 D) with a short recovery time.

While ICL is the preferred surgery for high myopia, there are limited studies on its use in correcting mild and moderate myopia. Comparing EVO-ICL and laser-assisted in situ keratomileusis (LASIK), ICL was found to be safer, more predictable, and more stable, with better contrast sensitivity and lower higher-order aberrations (HOAs). The current literature primarily compares the visual outcomes of ICL and SMILE in patients with high myopia.

The most extensive study conducted in this group was by Aruma et al where 32 eyes of 20 patients underwent EVO-ICL implantation, and 35 eyes of 19 patients underwent SMILE. Changes in coma after ICL were significantly less than after SMILE. The leading complaints after ICL and SMILE were halos (84.4%) and blurred vision (65.7%). A study by Ganesh et al in Indian eyes compared three procedures: Toric-ICL. Femtosecond LASIK and SMILE in 30 patients with low to moderate myopia over a one-year follow-up period concluded that the Quality of vision and patient satisfaction with Toric ICL and SMILE were similar and better than Femtosecond LASIK.

There are very few long-term studies, especially Indian studies, that compare the effects on vision quality objectively and subjectively after both procedures in cases of moderate myopia and myopic astigmatism; hence, the need to carry out this study. A more extensive population-based comparative analysis would be needed to compare the visual performance between the two procedures.