A PROSPECTIVE RANDOMIZED POST MARKET CLINICAL STUDY TO EVALUATE THE INCISION OF THE HOYA MULTISERT™ INJECTOR SYSTEM WITH VIVINEX™ PRE-LOADED INTRAOCULAR LENSES
- Conditions
- h25Senile cataract
- Registration Number
- DRKS00015266
- Lead Sponsor
- HOYA MEDICAL SINGAPORE PTE. LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- All
- Target Recruitment
- 97
All subjects of this study shall be/have:
1. Adult subjects with a minimum age of 55 years
2. Planned for cataract surgery
3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
4. Signed informed consent and any other documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
All subjects to be enrolled in this study shall not be/ not have:
1. Participating in this study with the other eye.
2. Previous intraocular and corneal surgery, including corneal refractive surgery, or retinal surgery on the study eye
3. Traumatic cataract in study eye
4. Strabismus, Amblyopia or Single Eye status
5. Contact lens wear within 2 months of the preoperative examination for PMMA contact lenses, within 1 month of the preoperative examination for gas permeable lenses, or within 3 weeks of the preoperative examination for extended-wear and daily-wear soft contact lenses in the study eye
6. Presence of corneal pathology (e.g. stromal, epithelial or endothelial dystrophy)
7. Acute, chronic, or uncontrolled systemic or ocular disease or illness that would increase the operative risk or confound the outcome of the study (e.g. poorly-controlled diabetes, immunocompromised, connective tissue disease, uncontrolled ocular hypertension, glaucomatous changes in the retina, chronic iritis/uveitis, retinal vessel disease, pseudoexfoliation syndrome etc.) or where healing processes are compromised
8. Pregnant, plan to become pregnant, are lactating or have another condition associated with the fluctuation of hormones that could lead to significant refractive changes.
9. Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Incision sizes <br>- Adverse events, adverse device effects<br>- Rate of wound leakage<br>
- Secondary Outcome Measures
Name Time Method