NCT02826421

Brief Summary

The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 28, 2017

Completed
Last Updated

July 2, 2018

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

July 5, 2016

Results QC Date

June 30, 2017

Last Update Submit

May 31, 2018

Conditions

Cataracts

Keywords

Intraocular lens

Outcome Measures

Primary Outcomes (1)

  • Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)

    Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.

    Day 0, operative day

Secondary Outcomes (1)

  • Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)

    Day 0, operative day

Study Arms (4)

UltraSert Preloaded Delivery System

EXPERIMENTAL

Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

Device: UltraSert Preloaded Delivery System

iTec Preloaded Delivery System

ACTIVE COMPARATOR

Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

Device: iTec Preloaded Delivery System

iSert Preloaded Delivery System

ACTIVE COMPARATOR

Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

Device: iSert Preloaded Delivery System

Monarch III D Manual IOL Delivery System

ACTIVE COMPARATOR

Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery

Device: Monarch III D Manual IOL Delivery System

Interventions

UltraSert Preloaded Delivery SystemDEVICE

Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject

UltraSert Preloaded Delivery System
iTec Preloaded Delivery SystemDEVICE

Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject

iTec Preloaded Delivery System
iSert Preloaded Delivery SystemDEVICE

Includes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject

iSert Preloaded Delivery System
Monarch III D Manual IOL Delivery SystemDEVICE

Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject

Monarch III D Manual IOL Delivery System

Eligibility Criteria

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

You may qualify if:

  • Able to comprehend and sign a statement of informed consent;
  • Willing and able to complete all required postoperative visits;
  • Cataract;
  • Planned cataract removal by phacoemulsification;
  • Calculated lens power from 18.0 through 27.0 D inclusive;
  • Preoperative astigmatism \<1.0D;

You may not qualify if:

  • Systemic disease that affects the cornea;
  • Any inflammation or edema of the cornea;
  • Previous or planned refractive or corneal surgery during the subject's participation in the study;
  • Previous corneal transplant;
  • Previous retinal detachment;
  • Pregnancy or lactation, current or planned, during the course of the study;
  • Current participation in another investigational drug or device study that may confound the results of this investigation;
  • Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 Research

    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
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 11, 2016

Study Start

July 4, 2016

Primary Completion

November 29, 2016

Study Completion

November 29, 2016

Last Updated

July 2, 2018

Results First Posted

July 28, 2017

Record last verified: 2017-07