NCT Number: NCT03316885
The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.
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Notify Me22 year and older
All sexes
Interventional
Not applicable
Alcon Investigative Site, Footscray, Victoria, Australia
Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye surgery).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Foldable, single-piece posterior chamber IOL intended for long-term use over the lifetime of the cataract patient. This device is CE-marked (European Conformity) in the countries with participating Investigators.
Other names: Model SY60WF
Routine small incision cataract surgery with unilateral IOL implantation
Time frame: Year 1 post-implantation from second eye surgery
Visual acuity (VA) was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical safety and performance endpoint (SPE) of 92.5% [as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014].
Time frame: Year 1 post-implantation from second eye surgery
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical SPE of 92.5% (EN ISO 11979-7:2014).
Time frame: Year 2 post-implantation from second eye surgery
VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 1 post-implantation from second eye surgery
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 1 post-implantation from second eye surgery
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Alcon Research
Industry
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