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Comparative Study of Two Multifocal Intraocular Lens With Different Add Power

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Yonsei University

Status

Completed

Conditions

Cataract

Treatments

Device: +2.75 diopters multifocal intraocular lens
Device: +3.25 diopters multifocal intraocular lens

Study type

Interventional

Funder types

Other

Identifiers

NCT02424162
4-2014-0837

Details and patient eligibility

About

This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.

Enrollment

43 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age >= 18
  • cataract patients with lens opacities classification higher than grade III
  • patients who desire to be spectacle indepence for distance and near vision

Exclusion criteria

  • previous ocular surgery or trauma
  • presence of corneal opacities
  • fundus abnormalities
  • glaucoma
  • uveitis
  • amblyopia
  • systemic disease
  • posterior capsule rupture during cataract surgery

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

43 participants in 2 patient groups

2.75 group
Experimental group
Description:
Patients with 2.75 diopters multifocal intraocular lens
Treatment:
Device: +2.75 diopters multifocal intraocular lens
3.25 group
Active Comparator group
Description:
Patients with +3.25 diopters multifocal intraocular lens
Treatment:
Device: +3.25 diopters multifocal intraocular lens

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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