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To evaluate the clinical parameters demonstrating the performance of the Active Sentry in two different pressure ( 20 & 50 mm of Hg) settings. This is a prospective, comparative, double arm, and single centre study.

To evaluate the clinical parameters demonstrating benefits of the Active Sentry in low Intraocular pressure (20 mm Hg) Vs high Intraocular pressure (55 mm Hg) settings. This is a prospective, comparative, double arm, and single centre study. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058235
Enrollment
112
Registered
2023-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: study group: phacoemulsification, for cataract removal, will be done using pressure settings of 20 mm Hg . Duration upto 2 minutes. Control Intervention1: nil: in this study both group

Sponsors

Alcon Laboratories Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cataract grade NS2 as per LOCS classification, Pupil dilatation > 6mm, ACD 2.6mm-4.5mm

Exclusion criteria

Exclusion criteria: any other ocular pathology,intra operative and post operative complications

Design outcomes

Primary

MeasureTime frame
Mean change in CCT pre and post operativeTimepoint: pre op ( baseline ) and post op day 1

Secondary

MeasureTime frame
BCVATimepoint: Post op Day 1;ECDTimepoint: Post op day 1 post op 1 month and post op 3 months

Countries

India

Contacts

Public ContactDr Chandrashekhar Wavikar

Wavikar Eye Hospital

drcmwavikar@wavikareye.com8104969600

Outcome results

None listed

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