Evaluating the safety and effectiveness of a new monofocal intraocular lens for cataract patients
Safety and Efficacy of the Bi-Aspheric Monofocal Intraocular Lens
This study is testing a new type of lens for cataract surgery to see how well it works and if it's safe for patients after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ICARES Medicus, Inc. Industry-sponsored |
| Locations | 1 site (Taoyuan, Guishan District) |
| Trial ID | NCT06380478 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who have received the aspicio™ Monofocal Intraocular Lens for cataract surgery. Participants will attend a follow-up visit at least three months post-surgery for a routine ophthalmological examination. Additionally, the study will review patients' medical records to gather data on visual acuity and any adverse events that occurred one month after the surgery. The study aims to assess the lens's performance and safety in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received the aspicio™ monofocal intraocular lens in at least one eye.
Not a fit: Patients with pre-existing ocular conditions that could impair visual acuity or those who have undergone previous ocular surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of the aspicio™ Monofocal Intraocular Lens, potentially improving cataract surgery outcomes.
How similar studies have performed: While this study is observational and focuses on a specific lens, similar studies evaluating intraocular lenses have shown promising results in improving visual outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects 18 years of age or older who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye 2. Willingness to cooperate with and complete all post-operative visits 3. Ability to comprehend and sign an informed consent Exclusion Criteria: 1. Any pathology that could reduce Visual Acuity (VA) (including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely narrow anterior chamber depth, microphthalmos, clinically significant macular/RPE changes, retinal detachment, corneal transplant, chronic sever uveitis, choroidal hemorrhage, recurrent severe inflammation of the anterior or posterior segment of unknown etiology, iris neovascularization, medically controlled or uncontrolled glaucoma, clinically significant macular degeneration, or diagnosis of pseudoexfoliation). 2. Previous ocular surgery (including YAG-laser) or trauma 3. Clinically significant irregular astigmatism 4. Concomitant severe eye disease 5. Pregnant or lactating 6. Any other ocular or systemic condition which, in the opinion of the investigator, should exclude the subject from the study 7. Concurrent participation in another drug or device investigation 8. May be expected to require other ocular surgery during the study
Where this trial is running
Taoyuan, Guishan District
- Chang Gung University Hospital — Taoyuan, Guishan District, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yih-Shiou Hwang, MD — Chang Gung University Hospital
- Study coordinator: Lisa Chen
- Email: lisa.phchen@gmail.com
- Phone: +88636579530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.