Clinical trial NCT04971863: In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens
Official title: In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens. Two-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Intraocular Lens Complication
Keywords: posterior capsule opacitication
incidence
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario La Fe
First posted: 2021-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects submitted to non-traumatic cataract surgery in at least 1 eye at the Hospital La Fé of Valencia, Spain

Brief summary: This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL.

Detailed description: This study is a two-arm masked clinical evaluation study of incidence of PCO after successful bilateral cataract surgery with implantation of a monofocal IOL. Subjects will be assessed 24 months after IOL implantation. Clinical evaluations will include incidence of adverse events, patient satisfaction questionnaire, as well as measurements of visual performance, optical quality, presence and intensity of PCO, presence and intensity of IOL glistening.

Eligibility criteria: Inclusion Criteria:

* Subjects 22 years or older submitted to cataract surgery in at least 1 eye and implanted with Asqelio monofocal or Clareon monofocal IOL

Exclusion Criteria:

* Any pathology reducing potential best-corrected visual acuity beyond 0.30 LogMAR, including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely shallow anterior chamber, microphthalmos, retinal detachment, severe recurrent anterior or posterior segment inflammation of unknown ethiology, iris neovascularization, uncontrolled glaucoma, clinically significant macular degeneration, or pseudoexfoliation diagnosis.
* Previous ocular surgery
* Rubella
* Surgery motivated by traumatic cataract
* Ocular trauma or refractive surgery
* Any other systemic or ocular condition that, in the investigator's opinion, should exclude the subject from study
* Requiring additional procedures due to intraoperatory complications, mechanical or surgical interventions for manipulating the pupil, excessive iris movility, significant vitreous loss, significant, anterior chamber hyphema, capsular annular breakage, or any other unrecognized ocular conditions that might compromise IOL positioning, as well as impossibility of locate the IOL in the capsular bag due to surgical complications.

Primary outcomes:
measure: Incidence of Posterior capsular opacity
timeFrame: 24 months after IOL implantation
measure: Intensity of Posterior capsular opacity
timeFrame: 24 months after IOL implantation
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 month, 6 months, 12 months and 24 months after IOL implantation
measure: Refraction
timeFrame: 1 month, 6 months, 12 months and 24 months after IOL implantation
measure: Optical quality
timeFrame: 24 months after IOL implantation
measure: Incidence of Glistening
timeFrame: 24 months after IOL implantation
measure: Intensity of Glistening
timeFrame: 24 months after IOL implantation
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico la Fe
Study officials:
References: