H26.9
Conditions
Interventions
Group 1: Single-arm
10-year follow-up of patients implanted with the AT LISA intraocular lens (IOL) who underwent cataract surgery or clear lens extraction.
All patients will have been treated accord
Sponsors
Oftalvist - Oftalmología Vistahermosa SL
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.- Patients aged 30 years or older who underwent cataract surgery or clear lens extraction with phacoemulsification and implantation of the AT LISA IOL. 2.- Patients who sign the informed consent form. 3.- Surgery performed at least 10 years ago
Exclusion criteria
Exclusion criteria: 1.- Patients participating in the clinical study. 2.- Any pathology that reduces best-corrected potential visual acuity beyond 0.30 logMAR (including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely shallow anterior chamber, microphthalmos, retinal detachment, corneal transplantation, severe recurrent inflammation of the anterior or posterior segment of unknown etiology, iris neovascularization, uncontrolled glaucoma, clinically significant macular degeneration, or diagnosis of pseudoexfoliation). 3.- Previous corneal surgery. 4.- Rubella or surgery due to traumatic cataract. 5.- Ocular trauma or refractive surgery. 6.- Any other ocular or systemic condition that, in the investigator’s opinion, should exclude the subject from the study. 7.- Subjects requiring additional procedures due to intraoperative complications, mechanical or surgical interventions to manipulate the pupil, excessive iris mobility, significant vitreous loss, significant hyphema in the anterior chamber, zonular or capsular rupture, or other unrecognized ocular conditions that may compromise IOL positioning, as well as inability to place the IOL in the capsular bag due to surgical complications, will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate distance visual acuity in patients 10 years after implantation of the AT LISA intraocular lens (IOL) following cataract surgery or clear lens extraction. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Evaluation of intermediate and near visual acuity. - Evaluation of refractive error. - Evaluation of the defocus curve. - Administration of two questionnaires on patient satisfaction and visual quality (NEI VFQ-25 and AIOLIS). | — |
Countries
Spain
Contacts
Public ContactPedro Tañá Rivero
Oftalvist
Outcome results
None listed