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Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric IOL Implantation Compared to Monofocal IOL Implantation

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: Toric T3 - T9 (Device); Monofocal (Device)

Phase: Phase 4

Status: Terminated

Sponsored by: Alcon Research

Summary

The objectives of this study are to assess and compare bilateral uncorrected distance visual acuity and distance spectacle independence post bilateral implantation of AcrySof Toric Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of eyeglass purchased and patient vision-related quality of life.

Clinical Details

Official title: Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric Intraocular Lens (IOL) Implantation Compared to Monofocal IOL Implantation

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Uncorrected Distance Visual Acuity

Spectacle Independence

Secondary outcome: Vision-related Quality of Life

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- are willing and able to understand and sign an informed consent;

- are willing and able to attend postoperative examinations per protocol schedule;

- are ≥ 21 years of age, of either gender and any race;

- have bilateral, age related, cataracts;

- have planned cataract removal via phacoemulsification with implantation of an

intraocular lens (IOL);

- are available to undergo second eye surgery within 6 weeks of the first eye surgery;

- are in good ocular health, with the exception of cataracts;

- are free of disease(s)/condition(s) listed in the "Precautions" section of the

AcrySof Toric and monofocal package inserts: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism and color vision deficiencies.

- have regular corneal astigmatism;

- qualify for bilateral AcrySof Toric IOLs on the AcrySof Toric Calculator

(www. acrysoftoriccalculator. com)

- are able to obtain pupil dilation ≥ 5. 0 mm

- are able to read and understand one of the following languages: Dutch, French, German

Exclusion Criteria:

- previous corneal surgery and/or reshaping

- abnormality, disease and/or conditions of the cornea (i. e. keratoconus, corneal

dystrophy, keratitis, corneal scar, etc.), which would clinically contra-indicate the implantation of a toric intraocular lens

- planned multiple procedures during cataract/IOL implantation surgery

- planned limbal relaxing incision (LRI), Excimer laser treatment or similar procedure

prior to or during the course of the study

- an ocular disease and/or condition that may compromise visual acuity levels (i. e.

glaucoma, diabetic retinopathy, amblyopia, etc.)

- pregnant, lactating or planning pregnancy during course of study. Subjects who become

pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results. Data will be collected on the CRF as observations.

Locations and Contacts

Contact Alcon Call Center for Trial Locations, Paris 75014, France
Additional Information

Starting date: June 2010
Last updated: October 19, 2012

Page last updated: August 23, 2015

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