MiLOOP-assisted cataract surgery for dense cataracts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares two cataract surgery approaches in adults with dense nuclear sclerosis. Participants are assigned to either the miLOOP-assisted method or standard phacoemulsification, with follow-up visits to monitor vision, endothelial cell health, and safety. The study aims to see if the miLOOP device reduces endothelial cell loss, lowers energy use, and improves visual outcomes without increasing risks. Outcomes include endothelial cell density, energy usage, safety events, and postoperative vision. The trial is conducted at a single center in Malaysia and is sponsored by Universiti Kebangsaan Malaysia Medical Centre.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Canselor Tuanku Muhriz
  Cheras, Kuala Lumpur, Malaysia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.