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Straylight after Cataract Surgery with Implantation of a Clareon or a Vivinex Monofocal Intraocular Lens

Straylight after Cataract Surgery with Implantation of a Clareon or a Vivinex Monofocal Intraocular Lens - In Vivo Straylight of Clareon/Vivinex IOLs

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49329
Enrollment
25
Registered
2020-05-01
Start date
2020-10-06
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

cataract

Interventions

With cataract surgery, the patient*s opacified lens is removed and replaced with a clear artificial IOL. The intervention in the present study consists of implanting a different, albeit very compara

Sponsors

Amphia Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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.

Exclusion criteria

Exclusion criteria: Any comorbidity that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, subjects with a history of ocular surgery, subjects with an increased risk of complicated cataract surgery, corneal astigmatism of >= 3 diopters

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is the amount of straylight, expressed as the logarithm of the straylight value (log[s]).

Secondary

MeasureTime frame
Secondary study parameters are 1) (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, 2) 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), 3) refractive error by means of automated refractometry, expressed as spherical equivalent (SEQ) refraction and as defocus equivalent (DEQ) refraction, 4) 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, and 5) presence (and severity) of any opacities in the ocular structures in the slit lamp photographs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)