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Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Sponsor: Universiti Kebangsaan Malaysia Medical Centre
Summary
The goal of this clinical trial is to find out if using the miLOOP device during cataract surgery confers additional protection against cornea (endothelial) cells loss by reducing the amount of ultrasound energy needed. It will also look at how well patients see after surgery and how safe the procedure is. The main questions it aims to answer are: * Does the miLOOP device reduce the loss of corneal endothelial cells during and after cataract surgery? * Does it reduce the amount of ultrasound energy used to remove dense cataracts? * Are vision and safety outcomes better with the miLOOP compared to standard surgery? Researchers will compare cataract surgery using the miLOOP device to standard cataract surgery without the device. Participants with dense cataracts will: * Be randomly assigned to have cataract surgery via conventional method or the miLOOP-assisted method * Attend follow-up visits to check vision, eye cell health, and any problems after surgery
Official title: EVALUATION OF MILOOP LENS FRAGMENTATION DEVICE IN PHACOEMULSIFICATION FOR DENSE CATARACTS: A RANDOMIZED CONTROLLED TRIAL
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2024-10-01
Completion Date
2026-12-31
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
The miLOOP utilizes a nickel-titanium (nitinol) loop to ensnare and exert centripetal cutting forces on the lens nucleus with decreasing loop diameter
Participants randomized to the intervention arm will undergo standard phacoemulsification cataract surgery with prior mechanical fragmentation of the dense crystalline lens nucleus using the miLOOP lens fragmentation device (Carl Zeiss Meditec AG). Nuclear fragmentation will be performed according to the manufacturer's recommended technique, followed by removal of the lens fragments using phacoemulsification with the Alcon Centurion Vision System and Intelligent Phaco technology. Intraoperative parameters including cumulative dissipated energy, ultrasound time, case time and fluid aspirated will be recorded.
Conventional phacoemulsification cataract surgery
Participants randomized to the control arm will undergo conventional phacoemulsification cataract surgery without use of the miLOOP lens fragmentation device. Lens nucleus fragmentation and removal will be performed using the Alcon Centurion Vision System via stop and chop technique. Intraoperative parameters including cumulative dissipated energy, ultrasound time, case time and fluid aspirated will be recorded.
Locations (1)
Hospital Canselor Tuanku Muhriz
Cheras, Kuala Lumpur, Malaysia