Senile Cataract Clinical Trial
Official title:
Safety and Efficacy of Implantation of Two Multifocal Intraocular Lenses in the Treatment of Senile Cataract: a Randomized Controlled Clinical Trial
Verified date | November 2016 |
Source | Qinghai University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | December 2018 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Qinghai University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Visual acuity | Best spectacle corrected visual acuity | at month 1, month 3, month 6, month 12 and month 24 after surgery | Yes |
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