In Vivo Straylight of Clareon/Vivinex IOLs
- Conditions
- Cataract
- Registration Number
- NL-OMON22813
- Lead Sponsor
- Coöperatie Medisch Specialistisch Bedrijf Amphia U.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 25
•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.
•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:
oLens subluxation or (phaco)iridodonesis,
oCataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract,
oHistory 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 <6 D or >30 D and Vivinex XY1 IOL <6 D or >30 D).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary study parameters are: <br>-The amount of straylight, expressed in log-units, over the course of 3 months after cataract surgery. <br>-(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,<br>-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). <br>-Refractive error by means of automated refractometry, expressed as spherical equivalent (SEQ) refraction and as defocus equivalent (DEQ) refraction. <br>-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.<br>-Presence (and severity) of any opacities in the ocular structures in the slit lamp photographs.