| CTRI Number |
CTRI/2025/06/089880 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of Rotational stability of Toric IOL |
|
Scientific Title of Study
|
Assessment of Toric IOL Rotational stability between three Toric 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 superspeciality eye hospital |
| Address |
ethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division, Room number 202, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru Bangalore KARNATAKA
Bangalore
KARNATAKA
560070
India |
| Phone |
9845129740 |
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SushmithaSamak Sriganesh |
| Designation |
Chief Research Officer |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
ethradhama Super Speciality Eye Hospital, Phacorefractive Department, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru Bangalore KARNATAKA
Bangalore
KARNATAKA
560070
India |
| Phone |
9448071800 |
| Fax |
|
| Email |
sush.samak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bala Harshita |
| Designation |
Phaco & refractive surgery fellows |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
ethradhama Super Speciality Eye Hospital, Phacorefractive Department, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru Bangalore KARNATAKA
Bangalore
KARNATAKA
560070
India |
| Phone |
9052924844 |
| Fax |
|
| Email |
drbalaharshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama superspeciality eye hospital, Kanakapura road, 7th block, Jayanagar, Bengaluru, Karnataka, India, 560070
|
|
|
Primary Sponsor
|
| Name |
Nethradhama superspeciality eye hospital |
| Address |
Nethradhama superspeciality eye hospital, Kanakapura road, 7th block, Jayanagar, Bengaluru, Karnataka, India, 560070
|
| 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 |
| DrBala harshitha |
Nethradhama superspeciality eye hospital |
Department of Phaco and Refractive services, 256/14, Kanakapura main road, 7th block Jayanagar, Bengaluru. Bangalore KARNATAKA
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
905292844
drbalaharshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To analyse and compare the rotational stability of three toric IOL’S- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson). |
to assess the rotational stability of the IOL by a dilated examination and itrace overlay and comparing the same between three study IOLS
|
| Comparator Agent |
To assess visual acuity between three toric IOLs’- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson). |
To assess compare the visual acuity at pod 15 and pod 3 months between the three study IOLs |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral implant; Eyes with grade 1-4 nuclear sclerosis, cortical cataracts, posterior subcapsular cataract
Eyes with regular corneal astigmatism 0.75-5D
In the bag IOL implantation
|
|
| ExclusionCriteria |
| Details |
Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts
Post refractive surgery, History of any previous ocular surgery
Complicated cataract
Glaucoma, posterior segment pathology retinopathy
History of uveitis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To analyse and compare the rotational stability of three toric IOL’S- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson). |
performed for 1 day, 2 weeks, and 3 months after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To assess visual acuity between three toric IOLs’- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson). |
performed for 1 day, 2 weeks, and 3 months after surgery. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
04/06/2026 |
| 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
|
MATERIALS AND METHODS: This prospective, interventional, single centre study will be approved by the institutional ethics committee of Nethradhama Super Speciality Eye Hospital and will adhere to the tenets of declaration of Helsinki. Verbal and written informed consent will be obtained from all patients participating in the study. PREOP VISIT Subjects will provide demographic information and medical history and will undergo the following visits at preoperative visit. · Visual acuity testing · Refraction · Slit lamp examination · IOP evaluation using NCT · Dilated fundus examination · Biometry using IOL Master 700 IOL power is calculated using Barrett TK Toric formula. All the eyes will be targeted for emmetropia. · Corneal topography – Pentacam (Oculus) – to rule out irregular astigmatism.
|