A prospective, multicenter clinical study comparing outcomes of two trifocal toric intraocular lens
- Conditions
- h25Senile cataract
- Registration Number
- DRKS00025969
- Lead Sponsor
- Biotech Europe Meditech Inc. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 84
1. Age of patient >21 Years
2. Patient diagnosed with cataract.
3. Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry
4. Calculated IOL power is within the range of investigational IOLs.
5. Patient willing to sign inform consent form.
6. Clear intraocular media other than cataract.
7. Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.
1. Previous intraocular or corneal surgery.
2. Traumatic cataract
3. Pregnancy (as stated by patient) or lactation.
4. Concurrent participation in another drug or device investigation.
5. Irregular astigmatism.
6. Patient receiving chlorquine treatment.
7. Subjects with any systemic disease that could increase operative risk or confound the outcome.
8. Active ocular disease in the operative eye other than cataract.
9. Vulnerable subjects as defined in section 12.3.9.
10. Corneal Astigmatism > 4.5 D
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary effectiveness endpoint is binocular distance corrected intermediate visual acuity (BCIDVA) at 70 cms at 6 months post-operative, with a target of equivalency between the two IOLs.
- Secondary Outcome Measures
Name Time Method Adverse Events: Cumulative and persistent rates of adverse events in first operative eyes in comparison to ISO 11979-7:2018 SPE historical control grid rates. Success criteria for each type of event will be a rate not statistically greater than the control rate.<br>a) Cystoid macular oedema<br>b) Hypopyon<br>c) Endophthalmitis<br>d) Lens dislocation<br>e) Pupillary Block<br>f) Retinal Detachment<br>g) Secondary Surgical intervention<br>h) Corneal stroma oedema<br>i) Raised IOP requiring treatment