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

NCT00459303 | Completed Phase 4 Results DMC

• 1 other identifier: 05012006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

cataract; aspherical intraocular lenses; functional vision

Outcome Measures

Primary Outcomes (2)

• Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition

  Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments.

  average data of post-op 3rd, 6th, 12th week measurements

• Best Corrected Contrast Sensitivity in Photopic Condition

  Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the "EYEVIEW™ Functional Analysis Software" into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements. ( physiological range of contrast sensitivity: 1.5 cpd : 25\~82.5 ; 3 cpd: 30\~150 ; 6 cpd: 65 \~ 200 ; 12 cpd: 20 \~130 ; 18 cpd: 6.5 \~ 65 )

  average data of post-operative 3rd week, 6th week, 12th week measurements

Secondary Outcomes (2)

• Corneal High-order Aberrations

  pre-op & averate data of post-op 3rd, 6th, 12th week measurements

• Total Ocular High-order Aberrations

  average data of post-op 3rd, 6th, 12th week measurements

Study Arms (1)

intraocular lens

ACTIVE COMPARATOR

patients with bilateral clinical significant cataract reisiceved cataract surgeries and recieved spherial intraocuar lens(SA60AT, Alcon) in one eye and aspherical intraocular lens(Tecnis Z9000, AMO)in the other respectively.

Device: aspherical intraocular lens; Device: spherical intraocular lens

Interventions

aspherical intraocular lens DEVICE

implantation of aspherical intraocular lenses(AMO Tecnis Z9000)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)

Also known as: AMO Tecnis Z9000

intraocular lens

spherical intraocular lens DEVICE

implantation of spherical intraocular lenses(Alcon SA60AT Acrysof)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)

Also known as: Alcon SA60AT Acrysof

intraocular lens

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Limitations and Caveats

small sample size

Results Point of Contact

• Title: Fung-Rong Hu
• Organization: National Taiwan University Hospital

fungronghu@ntuh.gov.tw

+886223123456

Study Officials

• Pei-Yuang Su, MD

  National Taiwan Unoversity Hospital

  PRINCIPAL INVESTIGATOR

• Fung-Rong Hu, MD

  National Taiwan University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2007
• First Posted: April 11, 2007
• Study Start: October 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 17, 2014
• Results First Posted: February 17, 2014

Record last verified: 2013-12

Locations

TW (1)