Back to resultsCataract Refractive Suite Study
Primary Purpose
Cataracts
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cataract Refractive Suite (CRS)
Standard manual technique
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts
Eligibility 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.
Sites / Locations
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CRS
Manual
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02974140
First Posted
November 23, 2016
Last Updated
August 28, 2018
Sponsor
Alcon, a Novartis Company
1. Study Identification
Unique Protocol Identification Number
NCT02974140
Brief Title
Cataract Refractive Suite Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Management Decision
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
July 25, 2017 (Actual)
Study Completion Date
July 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon, a Novartis Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRS
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cataract Refractive Suite (CRS)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard manual technique
Intervention Description
Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique
Primary Outcome Measure Information:
Title
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1
Description
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.
Time Frame
Day 20-40 from second implantation
Secondary Outcome Measure Information:
Title
Cumulative Dissipated Energy (CDE)
Description
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.
Time Frame
Day 0 (operative day), each eye
Title
Estimated Aspiration Fluid Used During Surgery
Description
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.
Time Frame
Day 0 (operative day), each eye
Title
Phaco Aspiration Time Spent During Surgery
Description
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.
Time Frame
Day 0 (operative day), each eye
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Manager, GCRA
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Alcon Investigative Site
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Alcon Investigative Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cataract Refractive Suite Study
We'll reach out to this number within 24 hrs