RecruitingACTRN12624000425594

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

A randomized comparative study of corneal endothelial cell count in patients undergoing routine bilateral cataract surgery for age-related cataract using the Active Sentry handpiece versus the Ozil handpiece in phacoemulsification

Sponsor

RSSM Medical trading as Derwent Eye Specialists

Enrollment

84 participants

Start Date

Jul 29, 2024

Study Type

Interventional

Conditions

Corneal endothelial cell loss Cataract

Summary

Purpose of the Study To scientifically appraise a newer piece of technology (Alcon Active Sentry handpiece) to see if it is superior to existing commonly used technology. Cataract surgery can degrade the number of vital cells on the inner lining of the cornea which are essential to keeping the cornea clear. This study is to investigate whether a new piece of technology is superior to older technology in terms of protecting the cornea. Hypothesis There is an incremental beneficial effect of the newer Active Sentry handpiece on cataract surgical safety and outcomes.

Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This study from Derwent Eye Specialists is comparing two different types of handpieces used during cataract surgery to see which better protects the delicate cells lining the inner surface of the cornea (the clear front of the eye). During cataract surgery, ultrasound energy is used to break up the cloudy lens, and this process can sometimes damage these vital corneal cells — called endothelial cells. The newer Active Sentry handpiece is designed to reduce the amount of energy used and therefore protect these cells better than the older Ozil handpiece. Participants will have both eyes treated — each eye with a different handpiece — allowing a direct comparison within the same person. You may be eligible if you are aged 50–85 and are scheduled for routine bilateral (both eyes) cataract surgery for age-related cataracts. Your cataracts would need to be a specific moderate grade (NS2+ or NS3+). People with Fuchs' endothelial dystrophy, glaucoma, previous eye surgery, or very hard cataracts would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A post market trial of two different handpieces used during cataract surgery. Modern cataract surgery is a highly safe, efficient operation. Despite this, risks of cataract surgery are still apparent

A post market trial of two different handpieces used during cataract surgery. Modern cataract surgery is a highly safe, efficient operation. Despite this, risks of cataract surgery are still apparent including risks to the corneal endothelium which is the highly specialised non -renewable tissue on the inner aspect of the cornea. A critical level of corneal endothelial cells and quality is required to maintain corneal transparency. Cataract surgery does degrade the number and morphology of corneal endothelial cells and there is still a low risk of causing corneal decompensation in certain patients. The Active Sentry handpiece has an inbuilt fluids pressor sensor which stabilises the anterior chamber during cataract surgery leading to less pressure fluctuations. The Ozil handpiece doesn't have this feature. The handpiece is used during the phacoemulsification part of cataract surgery, typically around minutes of the 15 minute procedure on average. It will be used by an Ophthalmic surgeon. Phacomeulsification uses Ultrasound energy to emulsify the cataract into pieces that get aspirated up some tubing. Once this is done, an artificial lens implant is inserted into the eye. The phacoemulsification machine records the ultrasound time, aspiration time, cumulative dispersed energy during the operation and this data will be transferred to a spreadsheet.