NCT02910362

Brief Summary

This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior chamber during standard phacoemulsification surgery. What is known:

  • Fluidics control is determined to be one of the primary drivers of physician decision making in choosing phacoemulsification equipment.
  • Active pressure system fluidic control has a perceived and possibly real (based upon recent literature) improvement in intra-cameral IOP stability and reduced pressure fluctuations.
  • Improved fluidics can allow for reduced dynamic IOP fluctuations, in-the-bag positioned phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health post-operatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 28, 2017

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

September 13, 2016

Results QC Date

April 25, 2017

Last Update Submit

October 7, 2018

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

  • Number of Eyes With Stable IOP

    Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.

    intraoperative

Study Arms (2)

Alcon phacoemulsification equipment

EXPERIMENTAL

cataract surgery performed with the Alcon phacoemulsification equipment

Device: Alcon phacoemulsification equipment

AMO phacoemulsification equipment

ACTIVE COMPARATOR

cataract surgery with the AMO phacoemulsification equipment

Device: AMO phacoemulsification equipment

Interventions

Alcon phacoemulsification equipmentDEVICE

cataract surgery with Alcon phacoemulsification equipment.

Alcon phacoemulsification equipment
AMO phacoemulsification equipmentDEVICE

cataract surgery with AMO phacoemulsification equipment.

AMO phacoemulsification equipment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or greater
  • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
  • Subjects able to give informed consent
  • Nuclear Sclerotic cataract graded 2+ or 3+
  • Naturally dilated pupil size (in dim light) \> 4.0 mm (with no dilation medications) for both eyes
  • Preoperative corneal astigmatism of 2.5 D or less
  • Ages between 55 and 80
  • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

You may not qualify if:

  • Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
  • Intraoperative complications
  • Subjects with only one functional eye
  • Those with one eye having poor or eccentric fixation
  • Mild or severe cataracts, predominantly posterior subcapsular cataracts
  • High corneal astigmatism (i.e. those eyes displaying an oval contact image)
  • Those with corneal scarring or who have had corneal surgery including corneal laser surgery
  • Microphthalmos
  • Buphthalmos
  • Severe Dry eyes
  • Blepharospasm
  • Nystagmus
  • Keratoconus
  • Any other corneal or conjunctival pathology or infection.
  • Central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Eye Consultants

Tucson, Arizona, 85710, United States

Location

Limitations and Caveats

small population size

Results Point of Contact

Title
Sean McCafferty, MD
Organization
Arizona Eye Consultants
sjmccafferty66@hotmail.com
(520) 791-7401

Study Officials

  • Sean McCafferty, MD

    Arizona Eye Consultants

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 22, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 11, 2018

Results First Posted

July 28, 2017

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)