Retrospective Study on the Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens With Follow-up at 3 Months
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- AST Products, Inc.
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Best-corrected distance visual acuity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation
Investigators
Eligibility Criteria
Inclusion Criteria
- •50 years or older submitted to cataract surgery with binocular implantation of Asqelio Trifocal TFLIO130C IOL
- •Seeking spectacle independence after surgery
- •IOL power between +5.0D y +34.0D
- •Transparent ocular media, except for the cataract prior to surgery.
- •Potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery
Exclusion Criteria
- •Preoperatory corneal astigmatism greater than 1.0D
- •Previous corneal surgery or trauma
- •Irregular cornea (e.g. keratoconus)
- •Choroidal hemorrhage
- •Microftalmos
- •Severe corneal dystrophy
- •Uncontrolled or medically controlled glaucoma
- •Clinically significant macular changes
- •Severe concomitant ocular condition
- •Cataract not age-related
Outcomes
Primary Outcomes
Best-corrected distance visual acuity
Time Frame: 3 months after implantation
Best-corrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Defocus curve
Time Frame: 3 months after implantation
Binocular defocus curve with best correction for distance obtained varying mergence from -4.0D to +2.0D in 0.5D steps
Uncorrected distance visual acuity
Time Frame: 3 months after implantation
Uncorrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Uncorrected intermediate visual acuity
Time Frame: 3 months after implantation
Uncorrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Distance-corrected near visual acuity
Time Frame: 3 months after implantation
Distance-corrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Uncorrected near visual acuity
Time Frame: 3 months after implantation
Uncorrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Distance-corrected intermediate visual acuity
Time Frame: 3 months after implantation
Distance-corrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Secondary Outcomes
- Manifest Refraction(Preoperatively and 3 months after implantation)
- Adverse events(3 months after implantation)
- Patient-reported outcomes CATQuest9SF(3 months after implantation)
- Patient-reported outcomes PRSIQ(3 months after implantation)
- Patient-reported outcomes PRVSQ(3 months after implantation)