Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02529488
• Collaborator: (none)
• Enrollment: 167
• Arm: 1
• Actual Duration (Months): 21.6

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL	N/A

Detailed Description

This study will be conducted in regions where the test article is approved at the time of study start.

Study Design

• Study Type: Interventional
• Actual Enrollment: 167 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00
• Actual Study Start Date: Sep 7, 2015
• Actual Primary Completion Date: Nov 30, 2016
• Actual Study Completion Date: Jun 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TFNT00 AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation	Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL; Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient; Other Names: Model TFNT00

Outcome Measures

Primary Outcome Measures

1. Mean Binocular Defocus Visual Acuity (VA) [Day 20-40 and Day 120-180 from second eye implantation]

   Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;

• Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;

• Clear intraocular media other than cataract in both eyes;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;

• Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;

• Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;

• Pregnant or lactating;

• Expected to require ocular surgical or retinal laser treatment;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr Clinical Manager, Cataract, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02529488
• Other Study ID Numbers: ILH297-P002
• First Posted: Aug 20, 2015
• Last Update Posted: Jul 2, 2018
• Last Verified: Mar 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Cataract; Presbyopia

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 17 study centers located in Australia (4), Chile (3), Germany (2), Italy (2), Spain (2), Belgium (1), Great Britain (1), France (1), and Netherlands (1).
Pre-assignment Detail	Of the 167 enrolled, 16 subjects were exited as screen failures prior to being implanted. An additional 2 subjects satisfied the eligibility criteria for the study, but were also discontinued prior to being implanted. This reporting group includes all implanted subjects (149).

Arm/Group Title	TFNT00
Arm/Group Description	AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Period Title: Overall Study
STARTED	149
COMPLETED	145
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	TFNT00
Arm/Group Description	AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Overall Participants	149
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.9 (9.28)
Sex: Female, Male (Count of Participants)
Female	92 61.7%
Male	57 38.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	43 28.9%
Not Hispanic or Latino	100 67.1%
Unknown or Not Reported	6 4%

Outcome Measures

1. Primary Outcome

Title	Mean Binocular Defocus Visual Acuity (VA)
Description	Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.
Time Frame	Day 20-40 and Day 120-180 from second eye implantation

Outcome Measure Data

Analysis Population Description

This analysis population includes all eyes successfully implanted with the test article that had at least 1 postoperative visit, no previous surgery for correction of refractive errors, no preoperative ocular pathology or macular degeneration at any time, no pregnancy during the study, and no major protocol deviations (Best-Case Analysis Set).

Arm/Group Title	TFNT00 Visit 3A	TFNT00 Visit 4A
Arm/Group Description	AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 20-40 post second eye implantation	AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 120-180 post second eye implantation
Measure Participants	137	134
+2.00 Diopter (D)	0.570 (0.1893)	0.569 (0.1844)
+1.50D	0.404 (0.1610)	0.388 (0.1679)
+1.00D	0.209 (0.1386)	0.214 (0.1413)
+0.50D	0.069 (0.1438)	0.058 (0.1205)
0.00D	-0.030 (0.1155)	-0.037 (0.1069)
-0.50D	0.037 (0.1099)	0.043 (0.1180)
-1.00D	0.101 (0.1141)	0.100 (0.1099)
-1.50D	0.072 (0.1175)	0.065 (0.1302)
-2.00D	0.052 (0.1270)	0.044 (0.1316)
-2.50D	0.077 (0.1396)	0.066 (0.1338)
-3.00D	0.148 (0.1417)	0.130 (0.1377)
-3.50D	0.257 (0.1532)	0.256 (0.1551)
-4.00D	0.387 (0.1624)	0.384 (0.1530)
-4.50D	0.495 (0.1674)	0.491 (0.1583)
-5.00D	0.621 (0.1597)	0.617 (0.1548)

Adverse Events

Time Frame	Test article implantation through study completion, an average of 1 year.
Adverse Event Reporting Description	Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Arm/Group Title	TFNT00 - 1st Eye		TFNT00 - 2nd Eye		TFNT00 - Non-Study Eye		TFNT00 - Systemic
Arm/Group Description	All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 1st implanted eye		All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 2nd implanted eye		All eyes not implanted with a study lens		All subjects with attempted test article implantation (successful or aborted after contact with the eye).
All Cause Mortality
	TFNT00 - 1st Eye		TFNT00 - 2nd Eye		TFNT00 - Non-Study Eye		TFNT00 - Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/149 (0%)		0/148 (0%)		0/1 (0%)		3/149 (2%)
Serious Adverse Events
	TFNT00 - 1st Eye		TFNT00 - 2nd Eye		TFNT00 - Non-Study Eye		TFNT00 - Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/149 (2%)		4/148 (2.7%)		0/1 (0%)		11/149 (7.4%)
Cardiac disorders
Acute myocardial infarction	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Atrial fibrillation	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Myocardial infarction	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Eye disorders
Retinal detachment	2/149 (1.3%)		2/148 (1.4%)		0/1 (0%)		0/149 (0%)
Vision blurred	1/149 (0.7%)		0/148 (0%)		0/1 (0%)		0/149 (0%)
Gastrointestinal disorders
Lower gastrointestinal haemorrhage	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
General disorders
Device dislocation	0/149 (0%)		1/148 (0.7%)		0/1 (0%)		0/149 (0%)
Multi-organ failure	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Infections and infestations
Cellulitis	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Urinary tract infection	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Injury, poisoning and procedural complications
Humerus fracture	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Wrist fracture	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Investigations
Intraocular pressure increased	1/149 (0.7%)		0/148 (0%)		0/1 (0%)		0/149 (0%)
Optic nerve cup/disc ratio increased	1/149 (0.7%)		1/148 (0.7%)		0/1 (0%)		0/149 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Renal neoplasm	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Nervous system disorders
Cerebrovascular accident	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Visual field defect	1/149 (0.7%)		1/148 (0.7%)		0/1 (0%)		0/149 (0%)
Surgical and medical procedures
Eye operation	1/149 (0.7%)		0/148 (0%)		0/1 (0%)		0/149 (0%)
Intraocular lens extraction	1/149 (0.7%)		0/148 (0%)		0/1 (0%)		0/149 (0%)
Intraocular lens repositioning	0/149 (0%)		1/148 (0.7%)		0/1 (0%)		0/149 (0%)
Joint arthroplasty	0/149 (0%)		0/148 (0%)		0/1 (0%)		1/149 (0.7%)
Retinopexy	2/149 (1.3%)		1/148 (0.7%)		0/1 (0%)		0/149 (0%)
Vitrectomy	0/149 (0%)		1/148 (0.7%)		0/1 (0%)		0/149 (0%)
Other (Not Including Serious) Adverse Events
	TFNT00 - 1st Eye		TFNT00 - 2nd Eye		TFNT00 - Non-Study Eye		TFNT00 - Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/149 (14.1%)		21/148 (14.2%)		0/1 (0%)		0/149 (0%)
Eye disorders
Dry eye	15/149 (10.1%)		13/148 (8.8%)		0/1 (0%)		0/149 (0%)
Posterior capsule opacification	6/149 (4%)		8/148 (5.4%)		0/1 (0%)		0/149 (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.