IC-8 Apthera IOL New Enrollment Post Approval Study

Cataract Clinical Trial

Official title:

IC-8 Apthera IOL New Enrollment Post Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060041
• Other study ID #: SAIL-101-PAS2
• Status: Recruiting
• Start date: September 8, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: November 2023
• Source: AcuFocus, Inc.
• Contact: Danni Fisher
• Phone: 716-329-1162
• Email: danni.fisher[@]bausch.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 435
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• 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;
• Clear intraocular media in both eyes;
• Preoperative corneal astigmatism =1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation;
• Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL.

Exclusion Criteria:

• 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;
• Presence of ocular abnormalities;
• Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment;
• Previous corneal or intraocular surgery, except cataract surgery;
• History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
• Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study;
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye;
• Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study.
• Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Posterior Capsule Opacification
• Presbyopia

Locations

Country	Name	City	State
United States	Vance Thompson Vision - Alexandria	Alexandria	Minnesota
United States	Ophthalmic Partners, PC	Bala-Cynwyd	Pennsylvania
United States	Utah Eye Centers	Bountiful	Utah
United States	Vance Thompson Vision - Bozeman	Bozeman	Montana
United States	Argus Research Center	Cape Coral	Florida
United States	Reeve Woods Eye Center	Chico	California
United States	Trinity Research Group, LLC	Dothan	Alabama
United States	Price Vision Group	Indianapolis	Indiana
United States	Vance Thompson Vision - Omaha	Omaha	Nebraska
United States	Virdi Eye Clinic and Laser Vision Center	Rock Island	Illinois
United States	Northern New Jersey Eye Institute	South Orange	New Jersey
United States	Berkeley Eye Center	Sugar Land	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AcuFocus, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	PCO treatment visit (during the Nd:YAG laser procedure)
Other	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'	PCO treatment visit (during the Nd:YAG laser procedure)
Other	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)	24 Months post IC-8 Apthera IOL implantation
Other	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)	24 Months post IC-8 Apthera IOL implantation
Other	Rates of device deficiencies	Rates of device deficiencies in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be evaluated	24 Months post IC-8 Apthera IOL implantation
Other	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	24 Months post IC-8 Apthera IOL implantation
Primary	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	24 Months post IC-8 Apthera IOL Implantation
Primary	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.	24 Months post IC-8 Apthera IOL Implantation
Primary	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	24 Months post IC-8 Apthera IOL implantation
Primary	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	24 Months post IC-8 Apthera IOL implantation
Primary	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	24 Months post IC-8 Apthera IOL implantation
Primary	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	24 Months post IC-8 Apthera IOL implantation
Primary	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.	24 Months post IC-8 Apthera IOL implantation
Primary	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.	24 Months post IC-8 Apthera IOL implantation