Spherical Aberration on the Optical of Two Different Aspherical Intraocular Lenses

Cataract Clinical Trial

Official title:

Effect of Spherical Aberration on the Optical Quality After Implantation of Two Different Aspherical Intraocular Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224728
• Other study ID #: EK-12-256-0113
• Status: Completed
• Phase: N/A
• First received: July 14, 2017
• Last updated: July 17, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Hospital Hietzing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Bilateral age-related cataract

• Potential postoperative visual acuity of 1.0 Snellen

• No relevant ocular pathology other than cataract

• Written informed consent to surgery and participation in the study

Exclusion Criteria:

• Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases

• Optical media disturbances due to: corneal and vitreal opacity, PEX

• Preceding ocular trauma or ocular surgery within 6 months

• Inability to cooperate

• Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• intraocular lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Hietzing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modulation transfer function (MTF) at 3 months after surgery		3 months