AcrySof IQ Toric A-Code Post-Market Clinical Study

Cataract Clinical Trial

Official title:

AcrySof IQ Toric A-Code Post-Market Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350503
• Other study ID #: ILV814-P001
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: December 17, 2021

Study information

• Verified date: November 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.

Description:

Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 17, 2021
• Est. primary completion date: May 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of cataracts with planned cataract removal by phacoemulsification

• Calculated lens power within the available range

• Able to sign informed consent and complete all study visits

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye conditions as specified in the protocol

• Uncontrolled glaucoma

• Pregnancy, current or planned

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• AcrySof IQ Toric A-code IOL
Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient

Procedure:
• Cataract surgery
Removal of cataractous lens and implantation of IOL

Locations

Country	Name	City	State
Japan	Alcon Investigative Site	Hakodate	Hokkaido
Japan	Alcon Investigative Site	Hiroshima	Hiroshima Prefecture
Japan	Alcon Investigative Site	Miyakonojo	Miyazaki Prefecture
Japan	Alcon Investigative Site	Saga	Saga Prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00	IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.	Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
Other	Mean Absolute Value of IOL Rotation From Visit 00	IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.	Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
Other	Mean Uncorrected Distance Visual Acuity (UCDVA) by Visit	Visual acuity (VA) was tested under well-lit conditions with no refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.	Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
Other	Mean Best Corrected Distance Visual Acuity (BCDVA) by Visit	Visual acuity (VA) was tested under well-lit conditions with refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.	Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
Other	Mean Sub-Surface Nano Glistening (SSNG) Densitometry (Peak) by Visit	Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Peak value is the highest value in the IOL anterior surface light scattering densitometry.	Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
Other	Mean SSNG Densitometry (Area Analysis) by Visit	Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Area analysis value is an average value of the IOL anterior surface light scattering densitometry in a certain area.	Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
Other	Number of Device Deficiencies	A device deficiency was defined as an inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety, or performance.	Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
Other	Percentage of Eyes With Glistening by Visit	A slit lamp examination was conducted to determine the presence/absence of glistening particles on the implanted IOL. Glistening was reported by on a 4-point scale, where Grade 0 = no glistening; Grade 1 = mild glistening (50/mm3); Grade 2 = moderate glistening (100/mm3); and Grade 3 = severe glistening (200/mm3).	Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
Other	Number of Eyes With Posterior Capsule Opacification (PCO) by Visit	A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). The presence or absence of PCO was recorded. Clinical significance was determined by the investigator.	Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7
Other	Number of Eyes Receiving Nd:YAG Laser Treatment for Posterior Capsule Opacification (PCO) by Visit	A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). A neodymium-doped yttrium aluminum garnet (Nd:YAG) laser was used to treat posterior capsule opacification, with treatment determined by the investigator. The presence or absence of Nd:YAG laser treament was recorded.	Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7
Primary	Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)	IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.	Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)