| CTRI Number |
CTRI/2025/07/091433 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing outcomes between two phakic toric IOLs |
|
Scientific Title of Study
|
Comparison of visual outcomes, predicted vault and rotational stability of two Toric phakic IOLs |
| 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 Sri Ganesh |
| Designation |
Chief Medical Director |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA 560070 India
Bangalore
KARNATAKA
560070
India |
| Phone |
9845129740 |
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushmiths Sriganesh |
| Designation |
Chief Research Officer |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA 560070 India
Bangalore
KARNATAKA
560070
India |
| Phone |
9448071800 |
| Fax |
|
| Email |
sush.samak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varshitha C |
| Designation |
Phaco & Refractive Surgery |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA 560070 India
Bangalore
KARNATAKA
560070
India |
| Phone |
9731996886 |
| Fax |
|
| Email |
varshithachandrashekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| 256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore
|
|
|
Primary Sponsor
|
| Name |
Nethradhama Super Speciality Eye Hospital |
| Address |
256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Varshitha C |
Nethradhama Super Speciality Eye Hospital |
256/14, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9731996886
varshithachandrashekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To compare the predicted vault and rotational stability between the EVO TICL versus the Eyecryl phakic toric IOL in correcting myopic astigmatism |
To compare the predicted vault and rotational stability between the EVO TICL versus the Eyecryl phakic toric IOL in correcting myopic astigmatism |
| Comparator Agent |
Visual and refractive outcomes between the two |
To compare the Visual and refractive outcomes between the EVO TICL and the Eyecryl phakic toric IOL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with myopic astigmatism motivated to undergo correction who are less than 40 years of age
Best corrected Visual acuityof 20/40 or better.
Healthy tear film and ocular surface
Anterior chamber depth more than or equal to 2.8mm.
Endothelial cell count more than 2000 cells/mm2.
Absence of corneal ectatic diseases, corneal scars, absence of retinal pathologies
|
|
| ExclusionCriteria |
| Details |
Corneal ectatic diseases, corneal scars, retinal pathologies
Active ocular disease in the operating eye such as uveitis, glaucoma, diabetic retinopathy and corneal disorders including scars, opacities, and degenerations
Progressive or unstable myopia and/or astigmatism.
Previous ocular surgery.
Dysfunctional lens syndrome, any evidence of cataract.
Anterior chamber depth less than 2.8mm.
Endothelial cell counts less than 2000 cells/mm2.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the predicted vault and rotational stability between the EVO TICL versus the Eyecryl phakic toric IOL in correcting myopic astigmatism |
day 1, 2 weeks, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the Visual and refractive outcomes between the EVO TICL and the Eyecryl phakic toric IOL |
day 1, 2 weeks, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
13/08/2025 |
| 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="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
|
Pre operative: Patients satisfying the inclusion and exclusion criteria will undergo :Visual acuity assessment (Autorefractometer, subjective and cycloplegic refraction with tropicamide with phenylephrine).Intraocular pressure (IOP) recording by non-contact tonometry (Nidek Non-contact Tonometer NT-510).Detailed Slit lamp examination for anterior segment and posterior segment evaluation.Detailed indirect ophthalmoscopy for fundus examination Tomography with Pentacam + MS39.Keratometry with Autorefractokeratometer (TOPCON RM 8900).Corneal thickness measurement by ultrasound Pachymetry.White to white measurement by Pentacam, AS OCT (MS 39) and digital callipers.Anterior Chamber Depth( ACD) measurement with Pentacam and AS OCT (MS 39).AC OCT and MS 39 for angle to angle measurement and lens rise.ICL power calculation using calculator provided by the manufacturer.
Post operative examinations: Monitored for 2 hours after the surgery and IOP is checked every 30 minutes using an iCare tonometer to make sure the IOP is within normal limits. Following tests will be performed on day 1, 2 weeks, 3 months and 6 months.Uncorrected visual acuity (day 1, 2weeks, 3 months, 6 months).Corrected visual acuity (day 1, 2weeks, 3 months, 6 months). Subjective Refraction (day 1, 2weeks, 3 months). Intraocular pressure( day 1, 2 weeks, 3 months, 6 months). Slit lamp examination for clinical vault and angle (day 1,2 weeks, 3 months and 6 months).Position of the toric phakic IOL by dilated slit lamp examination (2 weeks, 3 months and 6 months. Dynamic Vault angle and height measurements using MS-39 (2 weeks, 3 months and 6 months).HDA (2weeks, 3 months and 6 months).iTrace for total higher order aberrations (2weeks, 3 months and 6 months). CSV 1000 for contrast sensitivity (2 weeks and 3 months) |