reading performance
Conditions
Interventions
All patients participating in this study have undergone bilateral implantation of either a TECNIS Eyhance IOL or a TECNIS PureSee IOL as part of routine cataract care. No medical interventions are the
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age =18 yearsBilateral implantation of either a TECNIS Eyhance IOL or a TECNIS PureSee IOL, performed as routine carePostoperative manifest spherical equivalent refraction between +0.50 D and -0.75 D in both eyesPostoperative manifest astigmatism =0.75 D in both eyesCDVA =0.1 logMAR (=0.8 decimal) in both eyesNormal reading abilitySufficient proficiency in the Dutch language to complete PROMs independently
Exclusion criteria
Exclusion criteria: Ocular comorbidity that may significantly affect visual acuity (e.g., macular degeneration, diabetic retinopathy, glaucoma)Systemic conditions that may significantly affect visual function (e.g., prior cerebral infarction)Presence of clinically relevant posterior capsule opacification on slit-lamp examinationIntra- or postoperative complications that significantly affect vision and have not resolved within 3 monthsSurgery of the second eye not performed within 3 months of surgery of the first eyeImplantation of different IOL types in both eyes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is mean reading speed (MEAN-RS) at 40 cm without reading spectacle correction, measured using the Dutch version of the Radner Reading Charts and expressed in wpm. MEAN-RS is calculated as the mean of the reading speeds (in wpm) across all sentences of the Radner Reading Chart that were read aloud in full, in accordance with the Radner protocol. The measurement is performed binocularly during the single study visit, 3–6 months after cataract surgery of the second eye. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum reading speed (MAX-RS) and reading acuity (RA) at 40 cm, without and with distance correctionMaximum reading speed (MAX-RS) and reading acuity (RA) at 66 cm, without and with distance correctionCritical print size (CPS) at 40 cm and 66 cm, without and with distance correctionProportion of patients achieving reading speed thresholds of =80, =100, and =120 wpm at print sizes logRAD 0.4, 0.5, and 0.6, at 40 cm without reading spectacle correctionUncorrected and corrected distance visual acuity (UDVA, CDVA) — monocular and binocularUncorrected and distance-corrected intermediate visual acuity (UIVA, DCIVA) at 66 cm — monocular and binocularUncorrected and distance-corrected near visual acuity (UNVA, DCNVA) at 40 cm — monocular and binocularCatquest-9SF-NL — functional vision in daily lifePRSIQ-NL — spectacle independenceGSIQ-NL — global spectacle independenceQoV-NL — quality of vision (symptoms such as glare and haloes)Patient satisfaction (single-item questionnaire)Relationship between CDVA and reading speed at 40 cm at logRAD 0.4, within each group | — |
Countries
Netherlands
Contacts
Public ContactN.J. Reus
Amphia Ziekenhuis
Outcome results
None listed