N/A
Completed N=125
Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
Aphakia · Cataract
Source: ClinicalTrials.gov NCT01292629 ↗
Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Visual Acuity — 121; 121 subjects
Summary
The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
121; 121 | — |
| SECONDARY Complications and Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
- Have clear intraocular media
- Have potential Best Corrected Visual Acuity of 20/40 or better
- Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse
Exclusion Criteria
- Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
- Are monocular
- Have current ocular infection
- Are taking systemic steroids or other anti-metabolites
- Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study
Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
Data sourced from ClinicalTrials.gov (NCT01292629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.