| CTRI Number |
CTRI/2025/10/096440 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two intra-ocular lenses in developmental cataract in children |
|
Scientific Title of Study
|
A Study to Compare Visual Outcomes of Enhanced Monofocal IOLs vs Monofocal IOLs in the Pediatric Age Group |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devashree Moktan |
| Designation |
Junior Resident Doctor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences · All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – India
South
DELHI
110029
India |
| Phone |
9354004677 |
| Fax |
|
| Email |
devashree.moktan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Agarwal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences · All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – India
South
DELHI
110029
India |
| Phone |
01126593050 |
| Fax |
|
| Email |
drtushar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tushar Agarwal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences · All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – India
South
DELHI
110029
India |
| Phone |
01126593050 |
| Fax |
|
| Email |
drtushar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences · All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – 110029 (India) |
| 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 |
| Dr Devashree |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences · All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – India
South
DELHI |
9354004677
devashree.moktan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H260||Infantile and juvenile cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cataract extraction plus monofocal intraocular lens implantation under general anaesthesia (Group B) |
general anaesthesia All cases of bilateral developmental cataract will be assessed, and based on the inclusion and exclusion criteria, they will be enrolled for the study. Using block randomization and computer generated numbers, patients will be divided into 2 groups. Group A: 20 patients will be assigned to Group A for whom Enhanced Monofocal IOL (Tecnis Eyehance, ICB00) will be inserted Group B: 20 patients will be assigned to Group B for whom Monofocal IOL (Tecnis Monofocal, ZCB00) will be inserted. Patients with Delta TK more than 1 D, Toric Monofocal IOL/Toric Enhanced Monofocal IOL will be placed. Preoperative workup will done (refer to the attached preoperative proforma for details). The IOL power will be calculated using Barrett’s Universal Formula using IOL Master 700 and the first residual myopic power will be selected as the power of IOL for implantation. Lens aspiration will be done using the Centurion Phacoemulsification System (CPS). Both eyes shall be operated within a week’s time and the patient shall be evaluated on post-operative day 1. Suture removal shall be done after 1 month. Post-operative evaluation for the study shall be conducted after 1 month, 6 months and 12 months |
| Intervention |
Cataract extraction plus enhanced monofocal intraocular lens implantation under general anaesthesia (Group A) |
All cases of bilateral developmental cataract will be assessed, and based on the inclusion and exclusion criteria, they will be enrolled for the study.
Using block randomization and computer generated numbers, patients will be divided into 2 groups.
Group A: 20 patients will be assigned to Group A for whom Enhanced Monofocal IOL (Tecnis Eyehance, ICB00) will be inserted
Group B: 20 patients will be assigned to Group B for whom Monofocal IOL (Tecnis Monofocal, ZCB00) will be inserted.
Patients with Delta TK more than 1 D, Toric Monofocal IOL/Toric Enhanced Monofocal IOL will be placed.
Preoperative workup will done (refer to the attached preoperative proforma for details).
The IOL power will be calculated using Barrett’s Universal Formula using IOL Master 700 and the first residual myopic power will be selected as the power of IOL for implantation.
Lens aspiration will be done using the Centurion Phacoemulsification System (CPS).
Both eyes shall be operated within a week’s time and the patient shall be evaluated on post-operative day 1.
Suture removal shall be done after 1 month.
Post-operative evaluation for the study shall be conducted after 1 month, 6 months and 12 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Bilateral developmental cataract with lens opacity obscuring red reflex and visual acuity less than 20/40
(0.3 logMAR)
Axial Length between 21-25 mm
Keratometry between 41-46D with no signs of ectasia
Horizontal WTW between 10.5-12 mm
Parents willing to enroll in the study and follow up |
|
| ExclusionCriteria |
| Details |
Near VA better than N8 (0.4 logMAR)
Presence of concomittant ocular pathogies like allergic conjunctivitis, nystagmus, microcornea, corneal ectasia, keratitis, corneal opacities, total cataract,partially absorbed cataract, microspherophakia, lens subluxation or dislocation, glaucoma, optic atrophy, uveitis and retinal detachment.
Cases with history of trauma.
Systemic disorders like intellectual disability, congenital rubella syndrome and Down’s syndrome.
Parents unwilling to enroll in study and follow up |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of children achieving binocular Unaided Near Vision N8 (0.4 logMAR) or better |
1 month, 6 month, 12 months after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of visual outcomes in both groups with respect to post operative UDVA, CDVA, UIVA and CIVA at 66cm, Subjection Refraction and Acceptance, Percentage of eyes with 0.5D of Target, Stereopsis, Contrast Sensitivity, Internal Higher Order Aberrations, Need for Near Aid
|
1 month, 6 month, 12 months after intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/11/2025 |
| 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 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
|
Visual rehabilitation for near is important for children undergoing cataract surgery due to increased demands for near work. The compliance for glasses and post-operative follow-ups in children is generally sub-optimal in developing countries. Multifocal IOLs are a good option for rehabilitation of unaided near vision, however they are associated with post-operative glare, halos and dysphotopisa and may not be suitable for eyes which may potentially grow in axial length. Enhanced monofocal IOLs may potentially provide better binocular uncorrected near to intermediate visual acuity due to their extended range of focus as compared to standard monofocal IOLs with comparable photic phenomenon.
This trial aims to study the optical performance of enhanced monofocal IOL versus standard monofocal IOL in pediatric age group with respect to binocular uncorrected near visual acuity. Secondarily, this trial will also compare the uncorrected and best-corrected distance and intermediate visual acuity, subjective refraction and acceptance, HOA, stereopsis (distance and near) and contrast sensitivity, need for near aid between the two groups. |