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NCT07898007
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Conditions: Cataract, Endothelial Cell Density, Cumulative Dispersive Energy
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 68
Sponsor: Universiti Kebangsaan Malaysia Medical Centre
Location: Hospital Canselor Tuanku Muhriz Cheras Kuala Lumpur
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
Eligibility Criteria
Inclusion Criteria:
1. age 40-year-old and above
2. capable to give informed consent
3. Advanced visually significant cataract with a minimum grade 4 nuclear sclerosis based on Lens Opacities Classification System III (LOCS III)
4. Best corrected visual acuity of 6/18 or worse using Snellen visual acuity chart
5. Willingness to cooperate with the doctors in the follow-up visits
Exclusion Criteria:
1. Eyes with significant anterior segment comorbidity besides an advanced cataract that could complicate the procedure including corneal opacity and zonulopathy
2. Presence of polar cataract
3. Co-existing glaucoma, cornea or retinal diseases
4. Presence of pseudoexfoliation
5. Poor pupil dilatation
6. Endothelial cell count (ECC) less than 2000 cells/mm2
7. Previous history of ocular surgery or trauma
8. History of uveitis
9. Complicated surgery such as intraoperative posterior capsule tear, zonular dialysis or conversion to extracapsular cataract extraction
Source: ClinicalTrials.gov (NCT07898007). StuddyBuddy aggregates publicly available trial information.