Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens
- Conditions
- Cataract
- Registration Number
- NCT06190925
- Lead Sponsor
- AST Products, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Refraction 3 months after implantation Manifest residual refraction after implantation of IOL using subjective refraction methods (D)
- Secondary Outcome Measures
Name Time Method Corrected Visual acuity at intermediate distance 3 months after implantation Visual acuity at 60cm with refractive correction for distance (LogMAR units)
Corrected Visual acuity at near distance 3 months after implantation Visual acuity at 40cm with refractive correction for distance (LogMAR units)
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)
Corrected Visual acuity at distance 3 months after implantation Visual acuity at 4m with refractive correction (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)
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".
Uncorrected Visual acuity at near distance 3 months after implantation Visual acuity at 40cm without correction (LogMAR units)
Rotational stability 3 months after implantation Change in IOL axis position determined with slit lamp (degrees)
Trial Locations
- Locations (1)
OftalVist Alicante
🇪🇸Alicante, Spain