IOL Implantation After KAMRA Inlay Removal
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|ClinicalTrials.gov Identifier: NCT03320473|
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : June 19, 2018
A. The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal.
B. The secondary purpose of the study is to determine whether there are any changes in biometry measurements before and after the inlay removal and how the changes affect the calculated IOL power.
|Condition or disease||Intervention/treatment||Phase|
|Cataract Presbyopia||Device: IC-8 IOL||Not Applicable|
This will be a prospective study in which no more than 20 subjects will be implanted with IC-8 IOL following the removal of the KAMRA inlay. The refractive target of the IC-8 eye will be -0.75 D MRSE.
Subjects will be screened for eligibility and consented before enrolled. Following enrollment, the inlay will be removed, and the eye will be monitored for corneal and refractive stability before the implantation of the IC-8 IOL. Corneal stability is defined as keratometry readings in each meridian within ± 0.50 D, and/or the stability of the corneal topography as determined by the principal investigator, over two consecutive visits at least two weeks apart. Refractive stability is defined as manifest refractive sphere and cylinder measurements that are each within ± 0.50 D over two consecutive visits at least two weeks apart, or based on investigator judgment. When corneal and refractive stability are achieved, the IC-8 IOL will be implanted following cataract extraction by phacoemulsification.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study of Small Aperture Intraocular Lens (IOL) Implantation in KAMRA Inlay Patients After Inlay Removal|
|Estimated Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||February 28, 2020|
Experimental: IC-8 IOL
IC-8 IOL implantation after removal of KAMRA ACI 7000 PDT inlay
Device: IC-8 IOL
The AcuFocus IC-8 intraocular lens (IC-8 IOL) is a one-piece hydrophobic acrylic posterior chamber IOL into which a circular mask with a small 1.36 mm central aperture has been embedded. The IOL mask works by extending the depth of focus and its design is based on the KAMRA corneal inlay, which operates under the principle of small aperture optics.
- BCDVA [ Time Frame: 3 months ]Mean monocular best-corrected distance visual acuity at three months is at least 0.3 logMAR
- UCNVA [ Time Frame: 3 months ]b.1. Mean monocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months is at least 0.3 logMAR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320473
|Contact: Nicholas Tarantino, OD||9495859511 ext email@example.com|
|Contact: Srividhya Vilupuru, OD, PhD||9495859511 ext firstname.lastname@example.org|
|Asian Eye Institute||Recruiting|
|Makati City, Philippines, 1200|
|Contact: Shiela De Castro +632 8982020 ext 510 SSDeCastro@asianeyeinstitute.com|
|Principal Investigator: Robert Ang, MD|
|Study Director:||Nicholas Tarantino, OD|