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A study to compare anatomical measurements of eye that is used to calculate the power of Intra-ocular Lens (IOL) measured by Elisars NOA.

Protocol for Comparison of ocular biometry measurements in NOA and IOLMaster 500. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/066295
Enrollment
275
Registered
2024-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H259- Unspecified age-related cataract

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Elisar Vision Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Visual acuity as tested within one week of the trial should be better than 6/18 will be selected for the study. 2. One eye of each patient should be selected by either randomly or the eye operated first. Inclusion for Controls 1. Patients said to be clinically normal by ophthalmologist. Inclusion for Cataract 1. Patients diagnosed with cataract graded using the LOCS grading method by ophthalmologist. 2. Eyes that are undergoing cataract surgery candidates in the clinic

Exclusion criteria

Exclusion criteria: 1. Presence of keratoconus or suspect keratoconus, a previous diagnosis of dry eye, history of any corneal disease or trauma, any kind of ocular surgery, and use of contact lens past month. 2. Eyes with retinopathy or maculopathy, eyes with a history of corneal disease, pseudophakic eyes. 3. Patients with corneal pathology, previous refractive surgery or abnormalities in the anterior segment.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is to compare the ocular biometry measurements captured by Elisar NOA and IOLMaster 500 device. The measured values will be compared with the limits indicated in the protocol.Timepoint: 12 weeks

Secondary

MeasureTime frame
The secondary endpoint of this study is to compare the predicted refractive error for the calculated IOL power of each patient in both Elisar NOA and IOLMaster 500 where the difference in the error is not more than 1D.Timepoint: 12 weeks

Countries

India

Contacts

Public ContactDr S Soundari

Dr Agarwals Eye Hospital

soundari404@gmail.com9840339659

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026