A randomised, subject-masked evaluation of visual function after bilateral implantation of two types of presbyopia-correcting multifocal intraocular lenses (IOLs): the Symfony-study

Completed

Conditions: presbyopia and cataract surgery
age-related long sight and removal of the natural lens of the eye and implantation of an artificial lens
10002693

Registration Number: NL-OMON42871

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Minimum 21 years of age
- Bilateral cataract
- Bilateral implantation of Tecnis Symfony or AT LISA tri 839 (same lens model in both eyes)
- Expected postoperative astigmatism <= 1.00 D
- IOL power calculation between +10.00 D and 32.00 D
- Expected postoperative best-corrected visual acuity of logMAR +0.3 or better
- Availability to undergo second eye surgery within 2 weeks of the first eye surgery
- Willing and able to comply with scheduled visits and other study procedures
- Signed informed consent

Exclusion Criteria

- Previous corneal surgery and/or reshaping
- Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy)
- Irregular astigmatism
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Extensive age related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen)
- Extensive visual field loss (e.g., glaucoma, CVA, etc.)
- Extensive diabetic macular disease
- Amblyopia, strabismus
- Keratoconus
- Pseudoexfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
- Suturing of incision required at time of surgery
- Complications during surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the binocular uncorrected visual acuity at 80 cm<br /><br>distance under both photopic and mesopic conditions 13 weeks postoperatively. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are: binocular (un)corrected visual acuity at far (4<br /><br>meters) and near (40 cm) under both photopic and mesopic conditions, reading<br /><br>performance, patient satisfaction, and complication profile. </p><br>