Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing

October 17, 2018 updated by: Lenstec Incorporated

A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery

This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tarpon Springs, Florida, United States, 34689
        • St. Luke's Cataract & Laser Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • operable cataracts in both eyes
  • require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes
  • </=1 diopter (D) of regular astigmatism in both eyes

Exclusion Criteria:

  • Intraocular surgery or laser treatment prior to cataract surgery
  • Severe dry eye
  • Presence of ocular infection
  • Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better
  • Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better
  • History of retinal detachment
  • Corneal decompensation
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
  • Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
  • Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tecnis Z9002 Intraocular Lens (IOL)
Device: Intraocular Lens (IOL)
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.
ACTIVE_COMPARATOR: Softec HD Intraocular Lens (IOL)
Device: Intraocular Lens (IOL)
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target versus Achieved Refraction
Time Frame: 3 Months Postoperative
3 Months Postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Uncorrected Visual Acuity
Time Frame: 3 Months Postoperative
3 Months Postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lenstec Incorporated

Investigators

  • Principal Investigator: J. Pitzer Gills, III, MD, St. Luke's Cataract and Laser Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (ESTIMATE)

November 29, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTHD-10-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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