Post-market surveillance study of the Presbia Flexivue Microlens for improvement of near vision in patients with presbyopia
- Conditions
- Presbyopia
- Registration Number
- DRKS00031214
- Lead Sponsor
- niversitätsklinikum Frankfurt der Goethe-Universität Frankfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 22
1. low ametropic presbyopic subjects with addition between +1.5 D and +3.5 D
2. preoperative spherical equivalent of +1.0 D to -0.75 D simultaneously cyl. <0.75 D
3. stable refraction before microlens implantation (no change of MRSE over 0.5 D in the last 6 months)
4. UNVA <20/50 (0.4 logMAR)
5. BCDVA >20/25
6. Monovision tolerance
1. Glaucoma, IOP >21mmHg
2. corneal thickness <480µm
3. pathology in the anterior ocular segment
4. corneal diseases
5. subjects with active or recurrent infection of eye or eyelids
6. subjects with chronic dry eye and resistance to therapy
7. subjects with irregular topography
8. subjects with retinal pathologies that affect visual rehabilitation
9. subjects with herpes zoster/simplex in past
10. steroid responders
11. subjects with uncontrolled diabetes or diabetic retinal changes
12. subjects with chronic systemic or topical corticosteroids and immunosuppressive therapie that would affect wound healing
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in uncorrected near and intermediate visual acuity
- Secondary Outcome Measures
Name Time Method Complication rate, Change in endothelial cell number