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Cataract Refractive Suite Study

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ClinicalTrials.gov Identifier: NCT02974140
Recruitment Status : Terminated (Management Decision)
First Posted : November 28, 2016
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

Study Description
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Brief Summary:
The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative

Condition or disease Intervention/treatment Phase
Cataracts Device: Cataract Refractive Suite (CRS) Procedure: Standard manual technique Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Evaluation of Refractive Predictability in Patients With or Without Corneal Astigmatism (Maximum Allowable up to 1.25D) When Using the Cataract Refractive Suite and Standard Manual Techniques
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : July 25, 2017
Actual Study Completion Date : July 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: CRS
First surgical eye randomized to Cataract Refractive Suite with second surgical eye (fellow eye) assigned to standard manual technique. Second eye surgery conducted within 7-14 days of the first eye surgery.
 Device: Cataract Refractive Suite (CRS)
Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery

Procedure: Standard manual technique
Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique
Active Comparator: Manual
First surgical eye randomized to standard manual technique with second surgical eye (fellow eye) assigned to Cataract Refractive Suite. Second eye surgery conducted within 7-14 days of the first eye surgery.
 Device: Cataract Refractive Suite (CRS)
Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery

Procedure: Standard manual technique
Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1 [ Time Frame: Day 20-40 from second implantation ]
    Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.


Secondary Outcome Measures :
  1. Cumulative Dissipated Energy (CDE) [ Time Frame: Day 0 (operative day), each eye ]
    Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

  2. Estimated Aspiration Fluid Used During Surgery [ Time Frame: Day 0 (operative day), each eye ]
    Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

  3. Phaco Aspiration Time Spent During Surgery [ Time Frame: Day 0 (operative day), each eye ]
    Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with bilateral cataracts;
  • Planned cataract surgery and implantation of ReSTOR +2.5 D multifocal intraocular lens (IOL) in both eyes;
  • Clear intraocular media, other than cataract, in study eye(s);
  • Willing and able to complete all required postoperative visits;
  • Able to comprehend and sign a statement of informed consent;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Significant irregular corneal astigmatism;
  • History of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease;
  • Previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment;
  • Any inflammation or edema (swelling) of the cornea;
  • Pregnant;
  • Other protocol-specified exclusion criteria may apply.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974140


Locations
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United States, Florida
Alcon Investigative Site
Panama City, Florida, United States, 32405
United States, Minnesota
Alcon Investigative Site
Stillwater, Minnesota, United States, 55082
United States, Texas
Alcon Investigative Site
Hurst, Texas, United States, 76054
Sponsors and Collaborators
Alcon, a Novartis Company
Investigators
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Study Director: Sr. Clinical Manager, GCRA Alcon, A Novartis Division
  Study Documents (Full-Text)

Documents provided by Alcon Research ( Alcon, a Novartis Company ):
Statistical Analysis Plan  [PDF] March 6, 2017
Study Protocol  [PDF] April 4, 2017

More Information
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Responsible Party: Alcon, a Novartis Company
ClinicalTrials.gov Identifier: NCT02974140    
Other Study ID Numbers: CTK246-P001
First Posted: November 28, 2016    Key Record Dates
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases