Evaluation of the Rotational Stability

Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: intraocular lens

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one group; one group receiving NIDEK intraocular lens	Device: intraocular lens; Implant NIDEK intraocular lens after cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The intraocular lens rotation	The angle of the intraocular rotation.	postoperative 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual acuity	Distance BCVA	postoperative 6 months
Adverse event	severity and causal relationship	postoperative 6 months

Collaborators and Investigators

• Sponsor: Nidek Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: BPF001C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No