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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42871

Enrollment

Registered

2016-11-02

Start date

2016-12-22

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

presbyopia and cataract surgery

Interventions

Cataract surgery with bilateral implantation of either a TECNIS® Symfony Extended Range of Vision IOL (Symfony IOL, Abbott) or an AT LISA trifocal 839MP IOL (Zeiss).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the binocular uncorrected visual acuity at 80 cm distance under both photopic and mesopic conditions 13 weeks postoperatively.	—

Secondary

Measure	Time frame
Secondary endpoints are: binocular (un)corrected visual acuity at far (4 meters) and near (40 cm) under both photopic and mesopic conditions, reading performance, patient satisfaction, and complication profile.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)