Cataract
Conditions
Keywords
cataract surgery, intraocular lens, multifocal refractive correction
Brief summary
The study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery. This clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.
Interventions
None listed
Sponsors
AST Products, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients submitted to cataract surgery and implanted with Asqelio Trifocal IOL TFLIO130C * Patients signing a consent form * Patients seeking spectacle-independence following surgery * IOL power between +5.00 and +34.00 D * Transparent intraocular media, except for the cataract prior to surgery, in both eyes * Postoperatory potential visual acuity of 20/25 or better.
Exclusion criteria
* Preoperatory corneal astigmatism greater than 0.75D * Patients not providing informed consent * Previous corneal surgery or trauma * Irregular cornea (i.e. keratoconus) * Choroidal hemorrhage * Microophthalmos * Severe corneal dystrophy * Uncontrolled or medically controlled glaucoma * Clinically significant macular changes * Severe concomitant ocular disease * Not age-related cataract * Severe optic nerve atrophy * Diabetic retinopathy * Ambyopia * Extremely shallow anterior chamber * Severe chronic uveitis * Pregnant or lactating * Rubella * Mature/Dense cataract sifficulting preoperative fundus assessment * Previous retinal detachment * Concurrent participation in other investigation using drugs or clinical devices * Expecting ocular surgery within the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Six months after implantation | Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures |
| Refraction | Six months after implantation | Manifest refraction both monocular and binocularly using subjective methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected visual acuity for intermediate | Six months after implantation | Monocular visual acuity for intermediate distance (60cm), without any additional correction, using ETDRS vision chart |
| Best-corrected visual acuity for intermediate | Six months after implantation | Monocular visual acuity for intermediate distance (60cm), with the best correction for distance, using ETDRS vision chart |
| Uncorrected visual acuity for near | Six months after implantation | Monocular visual acuity for near distance (40cm), without any additional correction, using ETDRS vision chart |
| Uncorrected visual acuity for distance (4m) | Six months after implantation | Monocular visual acuity for distance (4m), without any additional correction, using ETDRS vision chart |
| Contrast sensitivity function (CSF) | Six months after implantation | CSF with best correction, with and without induced glare, using the Clinical Trial Suite |
| Defocus curve | Six months after implantation | Defocus curve of visual performance varying the stimulus vergence from -4.0 D to +1.0 D in 0.5 D steps with the best correction for distance |
| Best-corrected visual acuity for near | Six months after implantation | Monocular visual acuity for near distance (40cm), with the best correction for distance, using ETDRS vision chart |
| Best-corrected visual acuity for distance (4m) | Six months after implantation | Monocular visual acuity for distance (4m), with the best correction for distance, using ETDRS vision chart |
Countries
Spain
Outcome results
None listed