Cataract, Intraocular Lens Complication
Conditions
Keywords
posterior capsule opacitication, incidence
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.
Interventions
None listed
Sponsors
Hospital Universitario La Fe
AST Products, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Posterior capsular opacity | 24 months after IOL implantation | Incidence of PCO |
| Intensity of Posterior capsular opacity | 24 months after IOL implantation | Intensity of PCO determined using LOCSIII Classification System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optical quality | 24 months after IOL implantation | Higher-order wavefront aberrations determined using a clinical wavefront analyzer |
| Visual acuity | 1 month, 6 months, 12 months and 24 months after IOL implantation | Best corrected distance visual acuity in LogMAR units using the ETDRS chart |
| Intensity of Glistening | 24 months after IOL implantation | Intensity of IOL glistening |
| Incidence of Glistening | 24 months after IOL implantation | Incidence of IOL glistening |
| Refraction | 1 month, 6 months, 12 months and 24 months after IOL implantation | Residual refractive error in diopters determined objectively |
Countries
Spain
Outcome results
None listed