Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines

• Sponsor: Intuor Technologies, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02910362
• Collaborator: Abbott Medical Optics (Industry)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Surgery	Device: Alcon phacoemulsification equipment; Device: AMO phacoemulsification equipment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Intra-surgical Evaluation of CATS Tonometer Prism and AMO Versus Alcon Phacoemulsification Machines
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alcon phacoemulsification equipment cataract surgery performed with the Alcon phacoemulsification equipment	Device: Alcon phacoemulsification equipment; cataract surgery with Alcon phacoemulsification equipment.
Active Comparator: AMO phacoemulsification equipment cataract surgery with the AMO phacoemulsification equipment	Device: AMO phacoemulsification equipment; cataract surgery with AMO phacoemulsification equipment.

Outcome Measures

Primary Outcome Measures

1. Number of Eyes With Stable IOP [intraoperative]

   Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• • 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

Exclusion Criteria:

• • 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)

• Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)

• Uncontrolled systemic or ocular disease

• History of ocular trauma or prior ocular surgery

• Fuchs Dystrophy

• Subjects who may be expected to require retinal laser treatment or other surgical intervention, including LRI's

• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)

• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)

• Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lens

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Eye Consultants	Tucson	Arizona	United States	85710

Sponsors and Collaborators

• Intuor Technologies, Inc.
• Abbott Medical Optics

Investigators

• Principal Investigator: Sean McCafferty, MD, Arizona Eye Consultants

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Intuor Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT02910362
• Other Study ID Numbers: CP-02
• First Posted: Sep 22, 2016
• Last Update Posted: Oct 11, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	From September 2016 until December 2016,15 patients were enrolled at Arizona Eye Consultants clinic
Pre-assignment Detail	Patients were included in the study based upon meeting inclusion criteria and not meeting exclusion criteria. Patients were randomized to either group based upon a random number generator.

Arm/Group Title	Alcon Phacoemulsification Equipment	AMO Phacoemulsification Equipment
Arm/Group Description	cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment.	cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment.
Period Title: Overall Study
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Alcon Phacoemulsification Equipment	AMO Phacoemulsification Equipment	Total
Arm/Group Description	cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment.	cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment.	Total of all reporting groups
Overall Participants	8	7	15
Overall Eyes	16	14	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (8)	66 (8)	66 (8)
Sex: Female, Male (Count of Participants)
Female	5 62.5%	4 57.1%	9 60%
Male	3 37.5%	3 42.9%	6 40%
Region of Enrollment (Count of Participants)
United States	8 100%	7 100%	15 100%

Outcome Measures

1. Primary Outcome

Title	Number of Eyes With Stable IOP
Description	Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.
Time Frame	intraoperative

Outcome Measure Data

Analysis Population Description

Eyes with stable IOP

Arm/Group Title	Alcon Phacoemulsification Equipment	AMO Phacoemulsification Equipment
Arm/Group Description	cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment.	cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment.
Measure Participants	8	7
Measure Eyes	16	14
Number [Eyes]	16	14

Adverse Events

Time Frame	4 months
Arm/Group Title	Alcon Phacoemulsification Equipment		AMO Phacoemulsification Equipment
Arm/Group Description	cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment.		cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment.
All Cause Mortality
	Alcon Phacoemulsification Equipment		AMO Phacoemulsification Equipment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Serious Adverse Events
	Alcon Phacoemulsification Equipment		AMO Phacoemulsification Equipment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Alcon Phacoemulsification Equipment		AMO Phacoemulsification Equipment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)

Limitations/Caveats

small population size

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.