| CTRI Number |
CTRI/2023/10/058767 [Registered on: 17/10/2023] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Identification of Errors by a new optical instrument |
|
Scientific Title of Study
|
Refractive accuracy & visual outcomes in eyes using Alcon Argos® Biometer |
| 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 Tanvi Haldipurkar Venkatramani |
| Designation |
Consultant – Cataract & Refractive Surgeries |
| Affiliation |
Laxmi Eye Hospital and Institute |
| Address |
Room No Unit 2, Second Floor,
Department of Ophthalmology, Division of Cataract and Refractive Surgeries,
Laxmi Eye Hospital and Institute,
Hamid Mulla Road,
Panvel 410206
Raigarh
MAHARASHTRA
410206
India |
| Phone |
02227452228 |
| Fax |
|
| Email |
tanuh8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanvi Haldipurkar Venkatramani |
| Designation |
Consultant – Cataract & Refractive Surgeries |
| Affiliation |
Laxmi Eye Hospital and Institute |
| Address |
Room No Unit 2, Second Floor,
Department of Ophthalmology, Division of Cataract and Refractive Surgeries,
Laxmi Eye Hospital and Institute,
Hamid Mulla Road,
Panvel 410206
Raigarh
MAHARASHTRA
410206
India |
| Phone |
02227452228 |
| Fax |
|
| Email |
tanuh8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanvi Haldipurkar Venkatramani |
| Designation |
Consultant – Cataract & Refractive Surgeries |
| Affiliation |
Laxmi Eye Hospital and Institute |
| Address |
Room No Unit 2, Second Floor,
Department of Ophthalmology, Division of Cataract and Refractive Surgeries,
Laxmi Eye Hospital and Institute,
Hamid Mulla Road,
Panvel 410206
Raigarh
MAHARASHTRA
410206
India |
| Phone |
02227452228 |
| Fax |
|
| Email |
tanuh8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alcon Laboratories India Pvt Ltd, 114, Marine Chambers, 11, Vitthaldas Thackersey Marg, New Marine Lines, Marine Lines, Mumbai, Maharashtra 400020 |
|
|
Primary Sponsor
|
| Name |
Alcon Laboratories India Pvt Ltd |
| Address |
11th Floor RMZ Azure Bellary Road Hebbal Bengaluru Pin 560092 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Tanvi Haldipurkar |
Laxmi Eye Hospital and Institute and Laxmi Charitable Trust |
Room No - G5, Department of Cataract and Refractive Surgery, Main Building, Laxmi Eye Institute, Hamid Mulla Road, Panvel -410206
Raigarh
MAHARASHTRA |
02227452228
tanuh8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Laxmi Eye Institute an Laxmi Charitable Trust Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, (2) ICD-10 Condition: H264||Secondary cataract, (3) ICD-10 Condition: H269||Unspecified cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with age related cataract
Patients willing to provide consent for study and to come for follow ups as required |
|
| ExclusionCriteria |
| Details |
i. Patients with prior history of ocular surgery or trauma
ii. Patients who underwent complicated cataract surgery or any additional procedures during cataract surgery
iii. Patients who had any post-operative complications
iv. Patients with any active ocular disease such as Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism
v. Patients who is not willing to sign Informed Consent Form for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The mean absolute error between predicted residual error by Argos® Biometer & post operative spherical equivalent. |
Screening
Day 1 assessment
Day 30 assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the accuracy of Argos® Biometer in estimating the IOL power in long axial length (26 mm or more) eyes & short axial length (22.5 mm or less) eyes |
Screening
Day 1 Assessment
Day 30 assessment |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/10/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
This prospective observational study aims at assessing the refractive accuracy and visual outcomes inpatients that underwent cataract surgery with IOL implantation in which IOL power was obtained using Argos® biometer. The post-operative visual acuity and refractive error will be compared with the preoperative visual acuity and predicted post-operative refractive error on Argos® biometer. The main purpose of this study is to determine if Argos can accurately estimate the IOL power in long and short axial length eyes and provide consistent and accurate post-operative results |