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Efficacy and Safety of the Lens Fragmentation Device in Cataract Patients Undergoing Phacoemulsification: A Prospective, Multicenter, Randomized, Controlled Study

Efficacy and Safety of the Lens Fragmentation Device in Cataract Patients Undergoing Phacoemulsification: A Prospective, Multicenter, Randomized, Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102232
Enrollment
Unknown
Registered
2025-05-12
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Interventions

Control group:Phacoemulsification cataract surgery and intraocular lens implantation
Experimental group:Phacoemulsification cataract surgery and intraocular lens implantation using a lens fragmentation device

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Cataract patients aged 60 years and above who are planned to undergo phacoemulsification and intraocular lens implantation;2. Cataract LOCS III nuclear hardness grading grade III-IV;3. Able and willing to comply with all treatment and follow-up plans;4. Voluntarily consent to participate in this study and sign a written informed consent form;

Exclusion criteria

Exclusion criteria: 1. Combined conditions such as amblyopia, strabismus, glaucoma, corneal diseases, severe fundus diseases, lens subluxation/zonule laxity, and other ocular diseases that may affect postoperative outcomes; 2. History of eye trauma, history of refractive surgery, or other ocular surgeries; 3. Undergoing surgery on the other eye during the study period; 4. Systemic diseases that may affect postoperative outcomes, such as patients with unstable blood sugar control in diabetes; 5. Other circumstances deemed by the investigator as unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Cumulative dispersed energy;

Secondary

MeasureTime frame
Anterior chamber inflammation;Uncorrected distance visual acuity;Corneal edema;Fundus conditions;Corneal thickness and endothelial cell number;Corrected distance visual acuity;IOL position;Intraocular pressure;

Countries

China

Contacts

Public ContactLixia Luo

Sun Yat-sen University Zhongshan Ophthalmic Center

luolixia@gzzoc.com+86 18665666679

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026