ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Rotational Stability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03247751
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.

Brief Summary:
To evaluate rotational stability of the investigational device implanted after cataract surgery.

Condition or disease Intervention/treatment Phase
Cataract Device: intraocular lens Not Applicable

Detailed Description:
The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens
Actual Study Start Date : June 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: one group
one group receiving NIDEK intraocular lens
Device: intraocular lens
Implant NIDEK intraocular lens after cataract surgery




Primary Outcome Measures :
  1. The intraocular lens rotation [ Time Frame: postoperative 6 months ]
    The angle of the intraocular rotation.


Secondary Outcome Measures :
  1. visual acuity [ Time Frame: postoperative 6 months ]
    Distance BCVA

  2. Adverse event [ Time Frame: postoperative 6 months ]
    severity and causal relationship



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults, 18 years or older
  • Subject who diagnosed unilateral or bilateral age-related cataract.
  • Potential postoperative BCVA of 0.2 log MAR (0.63) or better.
  • Calculated IOL power in within the range of investigational IOL.
  • Subject is able to understand, agree and sign the informed consent statement.
  • Subject is able and willing to comply with the postoperative follow-up examination schedule.

Exclusion Criteria:

  • Uncontrolled systemic or ocular disease.
  • Extremely shallow anterior chamber.
  • Previous intraocular and corneal surgery.
  • Traumatic cataract.
  • Pregnancy or lactation.
  • Concurrent participation in another drug and device clinical investigation.

Responsible Party: Nidek Co. LTD.
ClinicalTrials.gov Identifier: NCT03247751     History of Changes
Other Study ID Numbers: BPF001C
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases