Cataract
Conditions
Keywords
cataract surgery, intraocular lens
Brief summary
The goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to cataract surgery following standard clinical practice. The main questions it aims to answer are: How rotationally stable is the lens after implantation and how effective is in the correction of refractive astigmatism. Additionally, the visual performance at different distances will be assessed, as well as the patient-reported outcomes.
Interventions
None listed
Sponsors
AST Products, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients submitted to cataract surgery with phacoemulsification with bilateral implantation of Asqelio Trifocal Toric IOL to avoid residual astigmatism * Patient signing informed consent * Clear intraocular media, except for cataracts in both eyes prior to surgery * Monocular potential postoperative visual acuity of 20/25 or better
Exclusion criteria
* Corneal astigmatism lower than 0.75D * Patients who do not provide informed consent * Patients who do not understand the study procedure * Previous corneal surgery or trauma * Irregular cornea (e.g. keratoconus) * Choroidal hemorrhage * Microphtalmos * Severe corneal dystrophy * Uncontrolled or medically controlled glaucoma * Clinically significant macular changes * Concomitant severe eye disease * Non-age-related cataract * Severe optic nerve atrophy * Diabetic retinopathy * Proliferative diabetic retinopathy * Amblyopia * Extremely shallow anterior camera * Severe chronic uveítis * Pregnant or nursing * Rubella * Mature/dense cataract that makes it difficult to examine the fundus preoperatively. * Previous retinal detachment * Concurrent participation in other research with drugs or clinical devices * Expect to require another eye surgery during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refraction | 3 months after implantation | Manifest residual refraction after implantation of IOL using subjective refraction methods (D) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corrected Visual acuity at distance | 3 months after implantation | Visual acuity at 4m with refractive correction (LogMAR units) |
| Corrected Visual acuity at intermediate distance | 3 months after implantation | Visual acuity at 60cm with refractive correction for distance (LogMAR units) |
| Uncorrected Visual acuity at distance | 3 months after implantation | Visual acuity at 4m without correction (LogMAR units) |
| Uncorrected Visual acuity at intermediate distance | 3 months after implantation | Visual acuity at 60cm without correction (LogMAR units) |
| Uncorrected Visual acuity at near distance | 3 months after implantation | Visual acuity at 40cm without correction (LogMAR units) |
| Corrected Visual acuity at near distance | 3 months after implantation | Visual acuity at 40cm with refractive correction for distance (LogMAR units) |
| Rotational stability | 3 months after implantation | Change in IOL axis position determined with slit lamp (degrees) |
| Contrast sensitivity function | 3 months after implantation | Contrast sensitivity determined with best correction for distance, under photopic and mesopic conditions, with and without induced glare, using the Clinical Trial Suite (CTS, M&S Technologies, Niles, IL, EEUU) (Log CS units) |
| Patient reported outcomes - Satisfaction | 3 months after implantation | Patient reported outcomes obtained by means of the CATQuest9SF questionnaire. 9 items with 4 response options, ranging from 4 for very great difficulty/very dissatisfied to 1 for no difficulty/very satisfied, and a cannot decide additional option, which is treated as missing data. |
| Patient reported outcomes - Visual Symptoms | 3 months after implantation | Patient reported outcomes on incidence and intensity of visual symptoms obtained by means of a visual symptoms questionnaire. It explores the frequency, intensity and bothersome of 10 different and common visual symptoms. Patients are asked to respond with 4 response options to the frequency of the symptoms, from 1 for Never to 4 Very often, the intensity of the symptom, from 1 for None to 4 for Severe, and the level of bothersome of the symptom, from 1 for None to 4 for A lot. |
| Binocular defocus curve | 3 months after implantation | Defocus curve obtained in binocular conditions from +2.00D to -4.00D vergence in 0.5 steps (LogMAR units) |
Countries
Spain
Outcome results
None listed