Cataract Refractive Suite Study

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

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

Study Overview

• Status: Terminated
• Conditions: Cataracts
• Intervention / Treatment: Device: Cataract Refractive Suite (CRS); Procedure: Standard manual technique

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Panama City, Florida, United States, 32405
      • Alcon Investigative Site
  • Minnesota
    • Stillwater, Minnesota, United States, 55082
      • Alcon Investigative Site
  • Texas
    • Hurst, Texas, United States, 76054
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1	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.	Day 20-40 from second implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Dissipated Energy (CDE)	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.	Day 0 (operative day), each eye
Estimated Aspiration Fluid Used During Surgery	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.	Day 0 (operative day), each eye
Phaco Aspiration Time Spent During Surgery	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.	Day 0 (operative day), each eye

Collaborators and Investigators

• Sponsor: Alcon, a Novartis Company
• Investigators: Study Director: Sr. Clinical Manager, GCRA, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2017
• Primary Completion (ACTUAL): July 25, 2017
• Study Completion (ACTUAL): July 25, 2017

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (ESTIMATE): November 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTK246-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes