A randomized comparative study of the Active Sentry handpiece versus the Ozil handpiece in phacoemulsificatio

Not Applicable

• Conditions: Cataract; Corneal endothelial cell loss; Surgery - Other surgery; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12624000425594
• Lead Sponsor: RSSM Medical trading as Derwent Eye Specialists

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-08
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Patients aged 50-85 years undergoing routine bilateral cataract surgery for age related cataract
Patients' cataracts graded according to the Lens Opacities Classification System (LOCS) grading system, limited to NS2+ and NS3+
Any Intraocular lens (IOL) placed within the capsular bag
No associated procedures at the time of cataract surgery
Ability to consent to treatment

Exclusion Criteria

Fuchs endothelial dystrophy
Cornea guttata
Complicated cataract surgery
Patients diagnosed with Glaucoma or on treatment with Glaucoma drops
Associated procedures such as intra-operative pupil dilation
Shallow Anterior chambers (<2.5mm)
Brunescent or White cataracts
Previous intraocular surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central endothelial cell count at 3 months post-operatively compared to the baseline pre-operative level in both the Ozil and Active Sentry groups. [Corneal endothelial cell count using specular microscopy Baseline and 3 months postoperatively]

Secondary Outcome Measures

Name	Time	Method
Central corneal thickness at the 1 day, 1-week, 4-week and 3-month post-operative check <br>[Corneal pachymetry <br> 1 day, 1-week, 4-week and 3-month post-operatively ];Aspiration time [Seconds of aspiration through the handpiece during cataract surgery obtained from the phacoemulsification touchscreen Intraoperatively ];Ultrasound time [Seconds of Ultrasound time during cataract surgery obtained from the phacoemulsification touchscreen Intraoperatively ]