Cataract
Conditions
Interventions
Patients will receive a Clareon monofocal IOL in one eye and a Vivinex XY1 monofocal IOL in the other.
Sponsors
Coöperatie Medisch Specialistisch Bedrijf Amphia U.A.
Eligibility
Inclusion criteria
Inclusion criteria: • Diagnosis of cataract in both eyes, • Having consented to and is planned to undergo cataract surgery in both eyes, • Planned for implantation of a non-toric monofocal IOL, • A targeted refractive error of emmetropia, • Age of at least 18 years, • Willing and able to participate in both preoperative and postoperative examinations, and • Agreeing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: • Insufficient understanding of the Dutch language to comply with study procedures, • Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, glaucoma, diabetic eye disease, ocular surface disease, corneal dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident, • Subjects with a history of ocular surgery (e.g., corneal refractive surgery), • Subjects with an increased risk of complicated cataract surgery: o Lens subluxation or (phaco)iridodonesis, o Cataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract, o History of ocular trauma • Unability to be (reliably) measured with the C-Quant straylight meter, IOLMaster 700, and/or Pentacam, • Unability to be (reliably) photographed with slit lamp photography, • Corneal astigmatism of =3 diopters, • A calculated IOL power for emmetropia in any eye that is outside the available range (i.e., Clareon IOL 30 D and Vivinex XY1 IOL 30 D).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter is the amount of straylight, expressed as the logarithm of the straylight value (log[s]), in eyes with implantation of a Clareon monofocal IOL or a Vivinex XY1 monofocal IOL. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are: - The amount of straylight, expressed in log-units, over the course of 3 months after cataract surgery. - (Relative) pixel intensities of the cornea, the (pseudo)phakic lens, the posterior lens capsule, and any vitreous opacities in measurements with the Pentacam and the IOLMaster 700, - Uncorrected distance visual acuity (UDVA), (best-)corrected distance visual acuity (CDVA), determined with ETDRS visual acuity chart and expressed as the logarithm of the minimum angle of resolution (logMAR). - Refractive error by means of automated refractometry, expressed as spherical equivalent (SEQ) refraction and as defocus equivalent (DEQ) refraction. - Lens position, expressed as anterior chamber depth. Anterior chamber depth is defined as the distance from the central anterior corneal epithelium to the anterior part of the lens. - Presence (and severity) of any opacities in the ocular structures in the slit lamp photographs. | — |
Contacts
Public ContactNic Reus
Amphia Ziekenhuis
Outcome results
None listed