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Evaluation of the Rotational Stability

N

Nidek

Status

Completed

Conditions

Cataract

Treatments

Device: intraocular lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT03247751
BPF001C

Details and patient eligibility

About

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

Full description

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

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

95 participants in 1 patient group

one group
Experimental group
Description:
one group receiving NIDEK intraocular lens
Treatment:
Device: intraocular lens

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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