Identification of Errors by a new optical instrument

Active, not recruiting

• Conditions: Age-related nuclear cataract, (2) ICD-10 Condition: H264||Secondary cataract, (3) ICD-10 Condition: H269||Unspecified cataract,

• Registration Number: CTRI/2023/10/058767
• Lead Sponsor: Alcon Laboratories India Pvt Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-17
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients diagnosed with age related cataract Patients willing to provide consent for study and to come for follow ups as required.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean absolute error between predicted residual error by Argos® Biometer & post operative spherical equivalent.	Screening | Day 1 assessment | Day 30 assessment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Laxmi Eye Hospital and Institute and Laxmi Charitable Trust; 🇮🇳 Raigarh, MAHARASHTRA, India

Laxmi Eye Hospital and Institute and Laxmi Charitable Trust

🇮🇳Raigarh, MAHARASHTRA, India

Dr Tanvi Haldipurkar

Principal investigator

02227452228

tanuh8@gmail.com