Comparative Study of Two Multifocal Intraocular Lens With Different Add Power

Yonsei University

Status: Completed

Conditions: Cataract

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