The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.
Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.
Study Type
OBSERVATIONAL
Enrollment
435
Trinity Research Group, LLC
Dothan, Alabama, United States
RECRUITINGFeinerman Vision Center
Newport Beach, California, United States
Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment
Rates of additional Nd:YAG laser treatments in the eye implanted with the IC-8 Apthera intraocular lens (IOL) beyond the initial Nd:YAG laser treatment will be assessed through 24 months post IC-8 Apthera IOL implantation
Time frame: 24 Months post IC-8 Apthera IOL Implantation
Nd:YAG laser treatment outcome and/or complications
Nd:YAG laser treatment outcomes and/or complications in the eye implanted with the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation.
Time frame: 24 Months post IC-8 Apthera IOL Implantation
IOL related assessments
The appearance of the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation
Time frame: 24 Months post IC-8 Apthera IOL implantation
Rates of Secondary Surgical Interventions (SSIs)
Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be assessed through 24 months post IC-8 Apthera IOL implantation
Time frame: 24 Months post IC-8 Apthera IOL implantation
Rates of other serious adverse events
Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Time frame: 24 Months post IC-8 Apthera IOL implantation
Rates of ocular adverse events
Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Time frame: 24 Months post IC-8 Apthera IOL implantation
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Argus Research Center
Cape Coral, Florida, United States
RECRUITINGStephenson Eye Associates
Venice, Florida, United States
RECRUITINGVirdi Eye Clinic and Laser Vision Center
Rock Island, Illinois, United States
RECRUITINGPrice Vision Group
Indianapolis, Indiana, United States
RECRUITINGGrene Vision Group
Wichita, Kansas, United States
RECRUITINGOakland Eye
Birmingham, Michigan, United States
RECRUITINGVance Thompson Vision - Omaha
Omaha, Nebraska, United States
RECRUITINGEye Associates of New Jersey
Dover, New Jersey, United States
RECRUITING...and 4 more locations
Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire
Subjective responses to the QoV Questionnaire that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
Time frame: 24 Months post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ)
Subjective responses to the Small Aperture Patient Questionnaire (SAPQ) that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
Time frame: 24 Months post IC-8 Apthera IOL implantation