IC-8 Apthera IOL New Enrollment Post Approval Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorBausch & Lomb Incorporated
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
22 years of age or older, any race and any gender;
Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
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 visits;
Disqualifiers
Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye;
Irregular astigmatism in either eye;
History of retinal disease;
Active or recurrent anterior segment pathology;
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
435 Participants
are grouped into 1 trial groupGroup A: IC-8 Apthera intraocular lens (IOL) Group
Trial outcomes
Primary outcomes
1
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 Implantation2
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 Implantation3
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 implantation4
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 implantationOther outcomes
1
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)2
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)3
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 implantation4
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 implantationSponsors and contacts
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Source ClinicalTrials.gov