IC-8 Apthera IOL New Enrollment Post Approval Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| IC-8 Apthera intraocular lens (IOL) Group 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. |
Outcome Measures
Primary Outcome Measures
- Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment [24 Months post IC-8 Apthera IOL Implantation]
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
- Nd:YAG laser treatment outcome and/or complications [24 Months post IC-8 Apthera IOL Implantation]
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.
- IOL related assessments [24 Months post IC-8 Apthera IOL implantation]
The appearance of the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation
- Rates of Secondary Surgical Interventions (SSIs) [24 Months post IC-8 Apthera IOL implantation]
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
- Rates of other serious adverse events [24 Months post IC-8 Apthera IOL implantation]
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
- Rates of ocular adverse events [24 Months post IC-8 Apthera IOL implantation]
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
- Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire [24 Months post IC-8 Apthera IOL implantation]
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.
- Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ) [24 Months post IC-8 Apthera IOL implantation]
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.
Other Outcome Measures
- Nd:YAG laser technique details and/or settings [PCO treatment visit (during the Nd:YAG laser procedure)]
Nd:YAG laser technique and/or settings during treatment in an IC-8 Apthera intraocular lens (IOL) eye will be evaluated
- Investigator opinion of ease of YAG procedure [PCO treatment visit (during the Nd:YAG laser 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'
- Mean monocular and binocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) [24 Months post IC-8 Apthera IOL implantation]
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)
- Mean monocular and binocular distance corrected distance visual acuity (DCDVA), distance corrected intermediate visual acuity (DCIVA) and distance corrected near visual acuity (DCNVA) [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) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes (same units of measure for all measurements)
- Rates of device deficiencies [24 Months post IC-8 Apthera IOL implantation]
Rates of device deficiencies in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be evaluated
- Rates of loss of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of best corrected distance visual acuity (BCDVA) [24 Months post IC-8 Apthera IOL implantation]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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22 years of age or older, any race and any gender;
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Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
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Able to comprehend and have signed a statement of informed consent;
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Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
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Clear intraocular media in both eyes;
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Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation;
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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:
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Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye;
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Irregular astigmatism in either eye;
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History of retinal disease;
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Active or recurrent anterior segment pathology;
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Presence of ocular abnormalities;
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Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment;
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Previous corneal or intraocular surgery, except cataract surgery;
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History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
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Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study;
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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;
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Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study.
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Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Trinity Research Group, LLC | Dothan | Alabama | United States | 36301 |
| 2 | Reeve Woods Eye Center | Chico | California | United States | 95926 |
| 3 | Argus Research Center | Cape Coral | Florida | United States | 33909 |
| 4 | Vance Thompson Vision - Alexandria | Alexandria | Minnesota | United States | 56308 |
| 5 | Vance Thompson Vision - Bozeman | Bozeman | Montana | United States | 59718 |
| 6 | Vance Thompson Vision - Omaha | Omaha | Nebraska | United States | 68137 |
| 7 | Northern New Jersey Eye Institute | South Orange | New Jersey | United States | 07079 |
| 8 | Ophthalmic Partners, PC | Bala-Cynwyd | Pennsylvania | United States | 19004 |
| 9 | Berkely Eye Center | Houston | Texas | United States | 77027 |
| 10 | Berkeley Eye Center | Sugar Land | Texas | United States | 77478 |
| 11 | Utah Eye Centers | Bountiful | Utah | United States | 84010 |
Sponsors and Collaborators
- AcuFocus, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAIL-101-PAS2