Comparison of Functional Vision Provided by AMO Tecnis Z9000 and Alcon SA60AT Acrysof

Condition(s) targeted: Cataract

Intervention: AMO Tecnis Z9000 (Device); Alcon SA60AT Acrysof (Device)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Pei-Yuang Su, MD, Principal Investigator, Affiliation: National Taiwan Unoversity Hospital
Fung-Rong Hu, MD, Study Chair, Affiliation: National Taiwan University Hospital

This study is to compare intraindividually the functional vision provided by two different posterior chamber intraocular lenses: AMO Tecnis Z9000 and Alcon SA60AT Acrysoft. To see if the aspherical intraocular lenses provide better functional vision than traditional spherical intraocular lenses.

Official title: Intraidivisual Comparison of Functional Vision Provided by AMO Tecnis Z9000 and ALcon SA60AT Acrysof Posterior Chamber Intraocular Lenses

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome:

best corrected log contrast sensitivity at photopic condition

best corrected logMAR contrast acuity at both photopic and mesopic conditions

Secondary outcome:

Corneal high-order aberrations

Total ocular high-order aberrations

Detailed description: In this prospective study, 30 patients with bilateral catarct presenting for cataract surgery are randomly assigned to recieve an aspherical intraocular lens(AMO Tecnis Z9000) in one eye and a spherical intraocular lens(Alcon SA60AT Acrysof)in the other. All surgeries are performed by one experienced surgeon(Fung-Rong Hu,MD)with clear cornea small incision phacoemulsification and in-the-bag posterior chamber intraocular implantation.

The patients are followed for 3 months, and postoperative contrast sensitivity, contrast acuity, corneal & total ocular high-ordered aberrations are measured and compared intraidividually between two different IOL groups.

Outcome Measurement:

1. Contrast sensitivity testing: measured with spectacle correction for the target distance of three meters using wall-mounted FACT sine-wave grating chart with nine levels of contrast. The graphic contrast sensitivity is recorded as a log functional units on the y-axis and displayed for five spatial frequency targets (1. 5, 3, 6, 12, 18 cycles per degree (cpd))on x- axis.

2. Contrast acuity testing: measured with spectacle correction for the target distance of three meters using logMAR letter chart(Precision Vision®)represented on a wall-mounted illuminator cabinet. Two types of contrast charts are used, high contrast(Cat. No. 2103 SLOAN translucent chart)and low contrast(Cat. No. 2132 10% SLOAN translucent chart),and are tested under both photopic and mesopic conditions.

3. Pupil diameters: measured by Colvard infrared pupillometer (Oasis. Medical, Glendora, CA, USA )under both photopic and mesopic luminance levels.

4. Corneal aberration analysis: performed with TMS-4 (Tomey, Japan).The corneal HOAs are described with Zernike polynomials of 3rd-to 5th- order root-mean-square(RMS)of central 6mm diameter using VOLPro 6. 89 software(Fa. Sarver and Associates, Carbondale. Ill, USA).

5. Total ocular aberration analysis: performed with a Hartmann-Shack aberrometer(Zywave, Bausch & Lomb Inc., Rochester, New. York)under maximal mydriasis with Mydrin-P(phenylephrine hydrochloride 0. 5% and tropicamide 0. 5%, Santen).The wavefront errors were described using Zernike polynomials RMS for total HOA at pupil diameter of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at pupil diameter of 6 mm.

Data Analysis:

- Mann-Whitney U matched-paired test was used with STATA software

- P values of 0. 05 or less were considered statistically significant

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Bilateral cataracts, eligible for phacoemulsification with primary implantation of a

posterior chamber IOL

- Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

- Preoperative ocular pathology potentially affect visual acuity. EX: diabetic

retinopathy, macular degeneration, corneal opacity, glaucoma, visual field defect...etc.

- Previous ocular surgery. Ex: refractive surgery, vitreoretinal surgery...etc.

- Patients who cannot cooperative with the study procedures

National Taiwan University Hospital, Taipei, Taiwan; Recruiting
Pei-Yuang Su, Email: patsysu624@yahoo.com.tw
Pei-Yuang Su, MD, Principal Investigator

Starting date: October 2005
Last updated: April 10, 2007