Cataract Refractive Suite Study

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

Tracking Information

• First Submitted Date: November 23, 2016
• First Posted Date: November 28, 2016
• Results First Submitted Date: July 23, 2018
• Results First Posted Date: September 14, 2018
• Last Update Posted Date: September 14, 2018
• Actual Study Start Date: March 2, 2017
• Actual Primary Completion Date: July 25, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 28, 2018)

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.

• Original Primary Outcome Measures (submitted: November 23, 2016): Percentage of eyes in which the Manifest Refraction Spherical Equivalent (MRSE) at one month is ≤ 0.50 Diopter (D) relative to predicted MRSE [ Time Frame: Day 20-40 from second implantation ]

Current Secondary Outcome Measures (submitted: August 28, 2018)

• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: November 23, 2016)

• Cumulative dissipated energy (CDE) [ Time Frame: Day 0 (operative day), each eye ]
• Estimated aspiration fluid used [ Time Frame: Day 0 (operative day), each eye ]
• Phaco aspiration time [ Time Frame: Day 0 (operative day), each eye ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cataracts

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Device: Cataract Refractive Suite (CRS)
  • Procedure: Standard manual 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.
  Interventions:

  • Device: Cataract Refractive Suite (CRS)
  • Procedure: Standard manual technique

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 15, 2017): 39
• Original Estimated Enrollment (submitted: November 23, 2016): 375
• Actual Study Completion Date: July 25, 2017
• Actual Primary Completion Date: July 25, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02974140
• Other Study ID Numbers: CTK246-P001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alcon Research ( Alcon, a Novartis Company )
• Original Responsible Party: Same as current
• Current Study Sponsor: Alcon, a Novartis Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Sr. Clinical Manager, GCRA; Alcon, A Novartis Division

• PRS Account: Alcon Research
• Verification Date: August 2018