Status:
COMPLETED
Evaluation of Visual Function After Bilateral Implantation of EDOF IOLs
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Cataract Bilateral
Lens, Intraocular
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Since intermediate vision is becoming increasingly important in our day-to-day tasks, a new IOL was introduced (Acunex Vario) with this objective in mind. This IOL provides excellent vision at far and...
Detailed Description
INTRODUCTION AND RATIONALE Nowadays, the most common types of intraocular lenses (IOLs) to correct aphakia after cataract surgery consist of monofocal, multifocal or extended depth of focus (EDOF) IO...
Eligibility Criteria
Inclusion
- Minimum 18 years of age
- Bilateral cataract
- Bilateral implantation of either Acunex® Vario IOL or the Alcon AcrySof® IQ Vivity® IOL
- Expected postoperative astigmatism ≤ 1.00 D (use of femtosecond laser assisted cataract surgery (FLACS) AK's tolerated up to 1.5 D of corneal astigmatism preoperative)
- Bilateral implantation of a non-toric Acunex® Vario IOL or a non-toric Alcon AcrySof® IQ Vivity® IOL
- IOL power calculation between +10.00 D and +30.0 D
- Expected postoperative best-corrected visual acuity of logMAR 0.3 or better
- Availability to undergo second eye surgery on the same day or else within 2 weeks of the first eye surgery
- Willing and able to comply with scheduled visits and other study procedures
- Signed informed consent
Exclusion
- Previous corneal surgery and/or reshaping
- Corneal pathology (i.e., fuchs endothelial dystrophy (FED), irregular astigmatism, herpes simplex virus (HSV) keratitis
- Extensive age-related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen) and post-intravitreal injection (IVI)
- Extensive visual field loss (eg. glaucoma, cerebral vascular accident (CVA), hemianopsia, etc.)
- Extensive diabetic retinopathy
- Amblyopia, strabismus, diplopia
- Pseudo exfoliation 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)
- Cognitive cerebral or concentration disorders (e.g., dementia, Parkinson, stroke, etc.)
- Suturing of incision required at time of surgery
- Complications during surgery of the first eye.
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05335408
Start Date
May 2 2022
End Date
June 9 2023
Last Update
October 19 2023
Active Locations (1)
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1
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6229 HX