A comparison of intra- operative efficiencies and early post-operative outcomes of 2 phaco machines :LegionÂ® Phaco System and LaureateÂ® Phaco System

A comparison of intra- operative efficiencies and early post-operative outcomes of LegionÂ® Phaco System with LaureateÂ® Phaco System : prospective, randomized, comparative, double masked,single center study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/06/034388

Enrollment

108

Registered

2021-06-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: Phacoemulsification Surgery with Legion Phaco system: LEGIONâ?¢ is an advanced gravity-based phaco system with its fluid management system provides dependable anterior chamber stability

Eligibility

Inclusion criteria

Inclusion criteria: 1.Uncomplicated age-related cataracts- Nuclear Opalescence (NO) grade III (LOCS III classification) 2.Normal transparent cornea 3.Normal retina/fovea

Exclusion criteria

Exclusion criteria: 1.Age less than 40 or more than 75 2.Complicated cataracts-Traumatic cataract/ Subluxated cataract/ Post Uveitis Cataract/ Posterior Polar cataract 3.Ocular structural abnormalities- Floppy Iris Syndrome/ Presence of small pupils 4.Diseases/interventions on the cornea -Presence of Corneal dystrophies/corneal scars/opacities, LASIK 5.Presence of anterior chamber abnormalities like iris coloboma/lens coloboma, peripheral anterior synechiae or peripheral iridotomy 6.Pre-existing Glaucoma/Uveitis 7.Diseases of the retina - Age related macular degeneration, Diabetic Retinopathy

Design outcomes

Primary

Measure	Time frame
Mean difference in the Central Corneal Thickness(CCT) between the two groupsTimepoint: Pre operative and post operative day 1 CCT measurement	—

Secondary

Measure	Time frame
Mean Balanced Salt Solution volume usage between the two groupsTimepoint: Intra operative;Mean case time difference between the two groupsTimepoint: Intra operative;Mean difference in Anterior segment inflammation between the two groupsTimepoint: post-operative day 1;Mean difference in Central Corneal Thickness (CCT) between the two groupsTimepoint: pre-operative and post-operative month-1;Mean difference in the Endothelial Cell Count(ECC) between the two groupsTimepoint: pre-operative and post-operative month-1;Mean ultrasound time difference between the two groupsTimepoint: Intra operative	—

Measure

Time frame

Mean Balanced Salt Solution volume usage between the two groupsTimepoint: Intra operative;Mean case time difference between the two groupsTimepoint: Intra operative;Mean difference in Anterior segment inflammation between the two groupsTimepoint: post-operative day 1;Mean difference in Central Corneal Thickness (CCT) between the two groupsTimepoint: pre-operative and post-operative month-1;Mean difference in the Endothelial Cell Count(ECC) between the two groupsTimepoint: pre-operative and post-operative month-1;Mean ultrasound time difference between the two groupsTimepoint: Intra operative

—

Countries

India

Contacts

Public ContactDr Yash Kataria

Icare Eye Hospital and Post Graduate Institute

saurabhchoudhry@gmail.com0120-2477600

Outcome results

None listed

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