Cataract Refractive Suite Study

Sponsor
Alcon, a Novartis Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT02974140
Collaborator
(none)
39
3
2
4.8
13
2.7

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Cataract Refractive Suite (CRS)
  • Procedure: Standard manual technique
N/A

Study Design

Study Type:
Interventional
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 :
Mar 2, 2017
Actual Primary Completion Date :
Jul 25, 2017
Actual Study Completion Date :
Jul 25, 2017

Arms and Interventions

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

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 [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) [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 [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 [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

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Alcon Investigative Site Panama City Florida United States 32405
2 Alcon Investigative Site Stillwater Minnesota United States 55082
3 Alcon Investigative Site Hurst Texas United States 76054

Sponsors and Collaborators

  • Alcon, a Novartis Company

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Alcon, a Novartis Company
ClinicalTrials.gov Identifier:
NCT02974140
Other Study ID Numbers:
  • CTK246-P001
First Posted:
Nov 28, 2016
Last Update Posted:
Sep 14, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Subjects were recruited from 3 investigative sites located in the United States.
Pre-assignment Detail This reporting group includes all enrolled subjects (39).
Arm/Group Title All Study Subjects
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
STARTED 39
CRS (Left or Right Eye) 38
Manual (Fellow Eye) 38
COMPLETED 0
NOT COMPLETED 39

Baseline Characteristics

Arm/Group Title All Study Subjects
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 Participants 39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
67.7
(7.8)
Sex: Female, Male (Count of Participants)
Female
25
64.1%
Male
14
35.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
1
2.6%
White
38
97.4%
More than one race
0
0%
Unknown or Not Reported
0
0%

Outcome Measures

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
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

Outcome Measure Data

Analysis Population Description
Full Analysis Set with data available
Arm/Group Title Suite Manual
Arm/Group Description Cataract surgery using Cataract Refractive Suite Cataract surgery using standard manual technique
Measure Participants 36 36
Measure Eyes 36 36
Number [percentage of eyes]
80.6
69.4
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Full Analysis Set with data available
Arm/Group Title Suite Manual
Arm/Group Description Cataract surgery using Cataract Refractive Suite Cataract surgery using standard manual technique
Measure Participants 37 38
Measure Eyes 37 38
Mean (Standard Deviation) [percent-seconds]
3.396
(2.4620)
4.032
(2.6022)
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Full Analysis Set with data available
Arm/Group Title Suite Manual
Arm/Group Description Cataract surgery using Cataract Refractive Suite Cataract surgery using standard manual technique
Measure Participants 37 38
Measure Eyes 37 38
Mean (Standard Deviation) [ml]
58.6
(16.48)
54.0
(11.57)
4. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Full Analysis Set with available data
Arm/Group Title Suite Manual
Arm/Group Description Cataract surgery using Cataract Refractive Suite Cataract surgery using standard manual technique
Measure Participants 37 38
Measure Eyes 37 38
Mean (Standard Deviation) [seconds]
197.9
(77.06)
173.3
(57.89)

Adverse Events

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
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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/38 (0%) 0/38 (0%) 0/39 (0%)
Serious Adverse Events
Suite (Ocular) Manual (Ocular) Nonocular
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/38 (2.6%) 0/38 (0%) 0/39 (0%)
Eye disorders
Retinal Tear 1/38 (2.6%) 0/38 (0%) 0/39 (0%)
Other (Not Including Serious) Adverse Events
Suite (Ocular) Manual (Ocular) Nonocular
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/38 (0%) 0/38 (0%) 0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

Results Point of Contact

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
Responsible Party:
Alcon, a Novartis Company
ClinicalTrials.gov Identifier:
NCT02974140
Other Study ID Numbers:
  • CTK246-P001
First Posted:
Nov 28, 2016
Last Update Posted:
Sep 14, 2018
Last Verified:
Aug 1, 2018