An observational study in Cataract, Presbyopia and Posterior Capsule Opacification, sponsored by Bausch & Lomb Incorporated. Recruiting at 14 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Bausch & Lomb Incorporated · Observational
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.
Potential study subjects will be recruited from patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification in the IC-8 Apthera IOL eye which requires treatment with Nd:YAG laser capsulotomy
Exclusion Criteria:
Patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.
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
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
Nd:YAG laser technique details and/or settings
Nd:YAG laser technique and/or settings during treatment in an IC-8 Apthera intraocular lens (IOL) eye will be evaluated
Time frame: PCO treatment visit (during the Nd:YAG laser procedure)
Investigator opinion of ease of YAG procedure
Difficulty performing Nd:YAG laser treatment in an IC-8 Apthera intraocular lens (IOL) eye will be evaluated per scale of difficulty chosen by investigator from 'No difficulty' to 'Great difficulty'
Time frame: PCO treatment visit (during the Nd:YAG laser procedure)
Mean monocular and binocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA)
Mean monocular and binocular 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 (same units of measure for all measurements)
Time frame: 24 Months post IC-8 Apthera IOL implantation
Mean monocular and binocular distance corrected distance visual acuity (DCDVA), distance corrected intermediate visual acuity (DCIVA) and distance corrected near visual acuity (DCNVA)
Mean monocular and binocular distance corrected distance visual acuity (DCDVA), 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 (same units of measure for all measurements)
Time frame: 24 Months post IC-8 Apthera IOL implantation
Rates of device deficiencies
Rates of device deficiencies in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be evaluated
Time frame: 24 Months post IC-8 Apthera IOL implantation
Rates of loss of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of best corrected distance visual acuity (BCDVA)
The rates of each event of loss of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of best corrected distance visual acuity (BCDVA) between a study visit and a later study visit, the reason for the visual acuity loss, and the treatment/outcome of these instances will be assessed through 24 months post IC-8 Apthera intraocular lens (IOL) implantation
Time frame: 24 Months post IC-8 Apthera IOL implantation
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Bausch & Lomb Incorporated