Safety and Efficacy of Implantation of Two Multifocal Intraocular Lenses in the Treatment of Senile Cataract
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
This trial is designed to compare the biocompatibility and long-term visual outcomes of the Tecnis Z9001 and Acri.LISA 366D multifocal IOLs used for the treatment of senile cataract. The aim is to provide a safer biomaterial for senile cataract treatment, achieving better postoperative visual quality and fewer complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 9, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 17, 2016
November 1, 2016
1.4 years
November 9, 2016
November 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of cataract participants with good biocompatibility of intraocular lens implants
Good engraftment, epithelialization, no neovascularization, retained transparency, no host inflammatory reaction.
month 12 after surgery
Secondary Outcomes (1)
Visual acuity
at month 1, month 3, month 6, month 12 and month 24 after surgery
Study Arms (2)
the test group
EXPERIMENTALThe patients aged 50-80 years will be randomly assigned to implantation of Acri.LISA366D multifocal aspheric IOLs in the test group.
the control group
EXPERIMENTALThe patients aged 50-80 years will be randomly assigned to implantation of TecnisZ9001 multifocal aspheric IOLs in the control group.
Interventions
The implantation of Acri.LISA366D multifocal aspheric IOLs are used in the test group.
The implantation of TecnisZ9001 multifocal aspheric IOLs are used in the test group.
Eligibility Criteria
You may qualify if:
- Clinically diagnosed as age-related cataract.
- Corneal astigmatism \< 1.0 D
- Lens hardness, II-III
- Initial surgery on the eye
- Age 50-80 years
- Healthy and able to tolerate anesthesia and surgery
You may not qualify if:
- Glaucoma or secondary vision loss resulting from diabetes, hypertension, intracranial tumors and neurological diseases
- Fundus disease, corneal edema, corneal opacity, endophthalmitis, and/or iris adhesion.
- Prior experience of eye surgery
- Failure to make regular referrals
- Autoimmune disease, mental illness or other serious systemic disease
- Inability to cooperate with the researchers
- Inability to tolerate surgery
- Sensitivity, anxiety or the pursuit of perfection
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Ping Yu, Master
Affiliated Hospital of Qinghai University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2016
First Posted
November 17, 2016
Study Start
January 1, 2016
Primary Completion
June 1, 2017
Study Completion
December 1, 2018
Last Updated
November 17, 2016
Record last verified: 2016-11