Alexandria Study I - Safety and efficacy of the complementary fixOflex-CR1 intraocular implant for cataract surgery
- Conditions
- Eye Diseases
- Registration Number
- PACTR202106741373163
- Lead Sponsor
- EYEPCR B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1.Adults
2.Cataract patients classified using LOCS III Grating, Grade 1 (Nuclear), Grade 2 (Cortical) or Grade 3 (Posterior)
3.Suitable to receive a standard monofocal IOL having a power range between 15 and 25 diopters
4.4 Clear intraocular media other than cataract
5.No previous intraocular or corneal surgery
6.No traumatic cataract
7.Stability of keratometry or biometry measurements. No indication of corneal ecstatic conditions or other corneal dystrophies
8.No irregular astigmatism
9.No pregnancy potential or lactation
10.Not concurrent participation in another drug or device investigation
11.Availability for postoperative follow up
12.Ability to sign the inform consent form
1.Dense cataract
2.Cataract patients which also have additional anterior segment ophthalmic pathology (e.g. glaucoma, pseudoexfoliation syndrome).
3.Previous corneal surgeries (LASIK, PRK, CCL, etc)
4.Monocular patient
5.Patients who are not available for post operative follow up
6.6. Patients who cannot consent to their enrolment the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post operative Best Spectacle Corrected Visual Acuity (BSCVA), Post operative Uncorrected Visual Acuity (UCVA), Standard deviation of the refractive surprise (Intended - Achieved refraction), Intraocular lens centration and tilt.
- Secondary Outcome Measures
Name Time Method PCO incidence