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Completed

NCT Number: NCT05758883

Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)

The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center, Tucson, Arizona, United States

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About this study

A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
  • Able to comprehend and have signed a statement of informed consent
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)

Exclusion criteria

  • There are no exclusion criteria for this study

Treatment and study plan

Primary outcomes

  1. Rates of secondary surgical interventions (SSIs)

    Time frame: 3 years post IC-8 Apthera IOL implantation

    Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit

  2. Rates of other serious adverse events

    Time frame: 3 years post IC-8 Apthera IOL implantation

    Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit

  3. Rates of ocular adverse events

    Time frame: 3 years post IC-8 Apthera IOL implantation

    Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit

  4. Rates of subjective visual disturbances

    Time frame: 3 years post IC-8 Apthera IOL implantation

    Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s)

Other outcomes

  1. Monocular best-corrected distance visual acuity (BCDVA) in IC-8 Apthera eyes and fellow eyes

    Time frame: 3 years post IC-8 Apthera IOL implantation

    Monocular best-corrected distance visual acuity will be assessed at the Study visit in the IC-8 Apthera intraocular lens (IOL) eyes and in the fellow eyes

  2. Rate of intraocular lens (IOL) removals due to visual/optical reasons in the IC-8 Apthera eyes and fellow eyes

    Time frame: 3 years post IC-8 Apthera IOL implantation

    Rate of intraocular lens (IOL) removals (based on eyes with events) will be assessed at the Study visit in the IC-8 Apthera IOL eyes and in the fellow eyes

  3. Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA)

    Time frame: 3 years post IC-8 Apthera IOL implantation

    Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes

  4. Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA)

    Time frame: 3 years post IC-8 Apthera IOL implantation

    Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes

  5. Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes in postoperative Manifest Refraction Spherical Equivalent (MRSE) groups

    Time frame: 3 years post IC-8 Apthera IOL implantation

    Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes may be evaluated in postoperative Manifest Refraction Spherical Equivalent groups: -1.01 D to more myopic, -1.00 D to -0.50 D, -0.49 D to -0.25 D, -0.24 D to 0.00 D, +0.01 D to +0.25 D, +0.26 D to more hyperopic.

Sponsors and collaborators

Lead sponsor

AcuFocus, Inc.

Industry

Registry information

Official study title

Post-approval Follow-up Study of the IC-8 Apthera IOL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2023
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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