| CTRI Number |
CTRI/2025/11/097379 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study in adults with cataract to find out how well people can see after cataract surgery using an enhanced monofocal lens implant |
|
Scientific Title of Study
|
A prospective, single centre, observational study on the visual performance of an enhanced monofocal IOL post phaco-emulsification cataract surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Vivek Naik |
| Designation |
Junior Resident DNB ophthalmology |
| Affiliation |
Bhaktivedanta Hospital and research institute |
| Address |
Ophthalmology OPD, Department of ophthalmology, first floor, bhaktivedanta swami marg, sector 6, Srishti complex, Mira Road east, thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
8983643416 |
| Fax |
|
| Email |
shubhamnaik555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraj Bhagde |
| Designation |
Head of Ophthalmology department |
| Affiliation |
Bhaktivedanta hospital and research institute |
| Address |
Ophthalmology OPD, Department of ophthalmology, first floor, bhaktivedanta swami marg, sector 6, Srishti complex, Mira Road east, thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9833547425 |
| Fax |
|
| Email |
drsuraj.b@bhaktivedantahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Vivek Naik |
| Designation |
Junior resident DNB ophthalmology |
| Affiliation |
Bhaktivedanta hospital and research institute |
| Address |
Ophthalmology OPD, Department of ophthalmology, first floor, bhaktivedanta swami marg, sector 6, Srishti complex, Mira Road east, thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
8983643416 |
| Fax |
|
| Email |
Shubhamnaik555@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107. |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Swami Marg, Sector 6, sector 2, Srishti complex, Mira Road East, Thane, Maharashtra, India 401107 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shubham Vivek Naik |
Bhaktivedanta Hospital and Research Institute |
OPD No. 1, Navdvipa, New Building,Department of Opthalmology,first Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA |
08983643416
shubhamnaik555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Undergone bilateral implantation with Johnson and Johnson Tecnis Eyhance enhanced monofocal IOL.
Willingness to undergo minimum follow up period of 1 month after second eye cataract surgery.
Pre Op corneal astigmatism less than/equal to 0.75D
|
|
| ExclusionCriteria |
| Details |
Age 20-80 Years except cataract
History of trauma or previous ocular surgery.
Axial length over 25mm
Pre-existing corneal pathology.
Glaucoma or optic neuropathy.
Diabetic retinopathy or macular degeneration.
• Systemic conditions affecting neuro-ocular pathways.
• Intra-operative complications (e.g. posterior capsular rupture, IOL outside the bag)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate visual and refractive outcomes, as well as patient satisfaction after bilateral implantation of an enhanced monofocal intraocular lens (Eyhance IOL - Johnson and Johnson vision) with emmetropia as a target refraction. |
Day1, Day7, Day15, 1 Month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare visual outcomes with preoperative parameters and with established data from conventional monofocal IOLs.
To assess the extent of spectacle independence achieved by the patients for various visual functions and activities of daily living using Catquest-9SF questionnaire.
To assess the impact of various pupillary diameters in mesopic and photopic conditions on the intermediate visual acuity.
To evaluate contrast sensitivity under photopic and mesopic conditions.
To evaluate the Defocus curve - in uniocular and binocular conditions.
|
Day1, Day7, Day15, 1 Month. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
24/11/2025 |
| 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 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 prospective observational study evaluates the real-world visual performance of enhanced monofocal intraocular lenses (IOLs), specifically the Johnson & Johnson Vision Eyhance lens, implanted bilaterally after uncomplicated phacoemulsification. Beyond standard visual acuity testing for distance, intermediate, and near vision, the study assesses advanced parameters such as pupillometry (under mesopic and photopic conditions), contrast sensitivity, and defocus curves under uniocular and binocular settings. Patient-reported outcomes will be captured using the validated Catquest-9SF questionnaire. The goal is to provide a comprehensive understanding of visual quality and functionality with enhanced monofocal IOLs to inform better patient selection and counseling in cataract surgery.
|