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Trial record 22 of 420 for:    cataract AND intraocular lens

Safety and Efficacy of Implantation of Two Multifocal Intraocular Lenses in the Treatment of Senile Cataract

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ClinicalTrials.gov Identifier: NCT02966496
Recruitment Status : Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Qinghai University

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.

Condition or disease Intervention/treatment Phase
Senile Cataract Biological: Acri.LISA366D multifocal aspheric IOLs Biological: TecnisZ9001 multifocal aspheric IOLs Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Implantation of Two Multifocal Intraocular Lenses in the Treatment of Senile Cataract: a Randomized Controlled Clinical Trial
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: the test group
The patients aged 50-80 years will be randomly assigned to implantation of Acri.LISA366D multifocal aspheric IOLs in the test group.
Biological: Acri.LISA366D multifocal aspheric IOLs
The implantation of Acri.LISA366D multifocal aspheric IOLs are used in the test group.

Experimental: the control group
The patients aged 50-80 years will be randomly assigned to implantation of TecnisZ9001 multifocal aspheric IOLs in the control group.
Biological: TecnisZ9001 multifocal aspheric IOLs
The implantation of TecnisZ9001 multifocal aspheric IOLs are used in the test group.




Primary Outcome Measures :
  1. Number of cataract participants with good biocompatibility of intraocular lens implants [ Time Frame: month 12 after surgery ]
    Good engraftment, epithelialization, no neovascularization, retained transparency, no host inflammatory reaction.


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: at month 1, month 3, month 6, month 12 and month 24 after surgery ]
    Best spectacle corrected visual acuity



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966496


Sponsors and Collaborators
Qinghai University
Investigators
Principal Investigator: Ping Yu, Master Affiliated Hospital of Qinghai University

Responsible Party: Qinghai University
ClinicalTrials.gov Identifier: NCT02966496     History of Changes
Other Study ID Numbers: QinghaiUH_005
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases