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OpenTrials
Completed

NCT Number: NCT03247751

Evaluation of the Rotational Stability

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraocular lens

Device

Implant NIDEK intraocular lens after cataract surgery

Primary outcomes

  1. The intraocular lens rotation

    Time frame: postoperative 6 months

    The angle of the intraocular rotation.

Secondary outcomes

  1. visual acuity

    Time frame: postoperative 6 months

    Distance BCVA

  2. Adverse event

    Time frame: postoperative 6 months

    severity and causal relationship

Sponsors and collaborators

Lead sponsor

Nidek Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2017
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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