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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataracts
Interventions Device: Cataract Refractive Suite (CRS)
Procedure: Standard manual technique
Enrollment 39
Recruitment Details Subjects were recruited from 3 investigative sites located in the United States.
Pre-assignment Details This reporting group includes all enrolled subjects (39).
Arm/Group Title All Study Subjects
Hide Arm/Group Description Cataract extraction surgery with either Cataract Refractive Suite (CRS) or manual technique in the study eye, defined as the eye with the worst preoperative corrected distance visual acuity (CDVA), with the alternate procedure in the fellow eye
Period Title: Overall Study
Number of participants Number of units (eyes)
Started 39 78
CRS (Left or Right Eye) [1] 38 38
Manual (Fellow Eye) [2] 38 38
Completed 0 0
Not Completed 39 78
Reason Not Completed
Adverse Event             2            
Lost to Follow-up             1            
Study Terminated by Sponsor             36            
[1]
Cataract surgery using Cataract Refractive Suite, as randomized
[2]
Cataract surgery using standard manual technique
Arm/Group Title All Study Subjects
Hide Arm/Group Description Cataract extraction surgery with either CRS or manual technique in the study eye, defined as the eye with the worst preoperative corrected distance visual acuity (CDVA), with the alternate procedure in the fellow eye
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
This analysis population includes all eyes that were randomized and for which an intraocular lens (IOL) was successfully implanted (Full Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
67.7  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
25
  64.1%
Male
14
  35.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   2.6%
White
38
  97.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set with data available
Arm/Group Title Suite Manual
Hide Arm/Group Description:
Cataract surgery using Cataract Refractive Suite
Cataract surgery using standard manual technique
Overall Number of Participants Analyzed 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
 36 36
Measure Type: Number
Unit of Measure: percentage of eyes
80.6 69.4
2.Secondary Outcome
Title Cumulative Dissipated Energy (CDE)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set with data available
Arm/Group Title Suite Manual
Hide Arm/Group Description:
Cataract surgery using Cataract Refractive Suite
Cataract surgery using standard manual technique
Overall Number of Participants Analyzed 37 38
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
 37 38
Mean (Standard Deviation)
Unit of Measure: percent-seconds
3.396  (2.4620) 4.032  (2.6022)
3.Secondary Outcome
Title Estimated Aspiration Fluid Used During Surgery
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set with data available
Arm/Group Title Suite Manual
Hide Arm/Group Description:
Cataract surgery using Cataract Refractive Suite
Cataract surgery using standard manual technique
Overall Number of Participants Analyzed 37 38
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
 37 38
Mean (Standard Deviation)
Unit of Measure: ml
58.6  (16.48) 54.0  (11.57)
4.Secondary Outcome
Title Phaco Aspiration Time Spent During Surgery
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set with available data
Arm/Group Title Suite Manual
Hide Arm/Group Description:
Cataract surgery using Cataract Refractive Suite
Cataract surgery using standard manual technique
Overall Number of Participants Analyzed 37 38
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
 37 38
Mean (Standard Deviation)
Unit of Measure: seconds
197.9  (77.06) 173.3  (57.89)
Time Frame Surgery through study completion, an average of 1 month.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. "At risk" population for ocular AEs is reported in units of eyes. Two subjects had only 1 eye treated (39 overall subjects, 38 eyes in each group).
 
Arm/Group Title Suite (Ocular) Manual (Ocular) Nonocular
Hide Arm/Group Description Eyes for which the LenSx was activated and a laser cut was initiated Eyes for which the incision was initiated using standard manual techniques Subjects for which cataract surgery was conducted in one or both eyes
All-Cause Mortality
Suite (Ocular) Manual (Ocular) Nonocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%)   0/39 (0.00%) 
Hide Serious Adverse Events
Suite (Ocular) Manual (Ocular) Nonocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/38 (2.63%)   0/38 (0.00%)   0/39 (0.00%) 
Eye disorders       
Retinal Tear † 1  1/38 (2.63%)  0/38 (0.00%)  0/39 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Suite (Ocular) Manual (Ocular) Nonocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%)   0/39 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr. Global Brand Medical Affairs Lead, CDMA Surgical
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research ( Alcon, a Novartis Company )
ClinicalTrials.gov Identifier: NCT02974140    
Other Study ID Numbers: CTK246-P001
First Submitted: November 23, 2016
First Posted: November 28, 2016
Results First Submitted: July 23, 2018
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018