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. Identifier: NCT03247751
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : February 20, 2018
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

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

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. 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:
Lens Diseases
Eye Diseases