A prospective, randomized clinical study of two phakic toric implantable lenses to compare outcomes in patients with moderate to high myopia and astigmatism
- Conditions
- MODERATE TO HIGH MYOPIA WITH ASTIGMATISM
- Registration Number
- DRKS00025965
- Lead Sponsor
- Biotech Healthcare Holdings GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 86
1. Patients 21 years old or older.
2. Calculated IOL Power is within the range of the investigational IOLs
3. Corneal Cylindrical error within the range defined in the clinical investigation plan
4. Subject has monocular UCVA 0.5 LogMAR or worse
5. Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
6. Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction
is determined by the following criteria:
a. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
b. Two refractions were performed at least 7 days apart.
7. Subject, who is expected to have residual postoperative cylindrical refractive error of =1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.
8. Expected dilated pupil size at least large enough to visualize the axis marking.
9. Patients willing to attend all follow-up appointments
10. Patients must sign and be given a copy of the written Informed Consent form
11. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
1. Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
2. Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
3. Subject with ocular condition that may predispose the subject to future complications
4. Subject with previous intraocular or corneal surgery
5. Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
6. Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
7. Other condition associated with fluctuation of hormones
8. ACD measured from the endothelium lower than 2.8 mm
9. Concurrent participation in another drug or device evaluation.
10. Any cataract of any grade.
11. Coefficient of variation of endothelial cell area >0.45
12. Percent Hexagonality of endothelial cell shape = 45%
13. Monocular subject
14. Vulnerable subjects as defined in section 12.3.10
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean residual refractive error in the study lens population that is equivalent to the mean residual refractive error of the control lens within +/- 0.50 Diopters at the 6-months post-op visit.
- Secondary Outcome Measures
Name Time Method Adverse Events [Time Frame: Intraoperative, 1 week, 1, 3, 6 & 12 Months post-surgery or as and when occurs] - Cumulative and persistent rates of adverse events in first operative eyes in comparison to ISO 11979-7:2014 SPE historical control grid rates.<br>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