NCT02974140

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 2, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 14, 2018

Completed
Last Updated

September 14, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

November 23, 2016

Results QC Date

July 23, 2018

Last Update Submit

August 28, 2018

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cumulative Dissipated Energy (CDE)

    Day 0 (operative day), each eye

  • Estimated Aspiration Fluid Used During Surgery

    Day 0 (operative day), each eye

  • Phaco Aspiration Time Spent During Surgery

    Day 0 (operative day), each eye

Study Arms (2)

CRS

EXPERIMENTAL

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)Procedure: Standard manual technique

Manual

ACTIVE COMPARATOR

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)Procedure: Standard manual technique

Interventions

Cataract Refractive Suite (CRS)DEVICE

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

CRSManual
Standard manual techniquePROCEDURE

Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique

CRSManual

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alcon Investigative Site

Panama City, Florida, 32405, United States

Location

Alcon Investigative Site

Stillwater, Minnesota, 55082, United States

Location

Alcon Investigative Site

Hurst, Texas, 76054, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Sr. Global Brand Medical Affairs Lead, CDMA Surgical
Organization
Alcon, A Novartis Division
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Sr. Clinical Manager, GCRA

    Alcon, A Novartis Division

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 28, 2016

Study Start

March 2, 2017

Primary Completion

July 25, 2017

Study Completion

July 25, 2017

Last Updated

September 14, 2018

Results First Posted

September 14, 2018

Record last verified: 2018-08

Locations

US(3)