Cataract, Intraocular Lens Complication, Intraocular Lens Opacification, Pseudophakia
Conditions
Brief summary
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens. The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power. The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 690AD or 690ADY IOLs mono- or binocularly between June 2022 - September 2023. Data from five visits will be collected: * Baseline preoperative (maximum 90 days prior to surgery)- retrospective * IOL implantation Day 0 - retrospective * Postoperative visit at Day 1 (+/- 0 days) - retrospective * Postoperative visit at 1 month (+/- 2 weeks) - retrospective * Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit
Interventions
DIAGNOSTIC_TESTStandard of care
12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.
BEHAVIORALPatient satisfaction questionnare
VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.
Sponsors
Medicontur Medical Engineering Ltd
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Adult males or females above 18 years of age; * Pseudophakic patients implanted with 690AD or 690ADY monofocal IOLs (implanted between June 2022 - September 2023); * Diagnosis of cataract and/or ametropia (hyperopia, myopia); * Subject who has signed an informed consent form. * Patients who have participated in all visits that are subject to retrospective data collection.
Exclusion criteria
* Patients who are not targeted to emmetropia. * Patients with the following condition(s) at the time of the baseline visit: * Corneal astigmatism \> 1.0D * Uncontrolled diabetic retinopathy * Iris neovascularization * Congenital eye abnormality * Uncontrolled glaucoma * Pseudoexfoliation syndrome * Amblyopia * Uveitis * AMD (advanced AMD) * Retinal detachment * Prior ocular surgery in personal medical history * Previous laser treatment * Corneal diseases * Severe retinal diseases (dystrophy, degeneration) * High myopia * Inadequate visualization of the fundus on preoperative examination * Patients deemed by the clinical investigator because of any systemic disease * Pregnancy * Eye trauma in medical history * Current use of systemic steroids or topical ocular medication * Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular corrected distance visual acuity (CDVA) | 12 months postoperatively | To compare monocular corrected distance visual acuity (CDVA) between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UDVA and CDVA | 12 months postoperatively | To compare percentage of eyes that achieve monocular UDVA and monocular CDVA within logMAR 0.0 or 0.3 between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively. |
| Monocular uncorrected distance visual acuity (UDVA) | 12 months postoperatively | To compare monocular uncorrected distance visual acuity (UDVA) between groups implanted with 690AD and 690ADY monofocal IOLs 12 months postoperatively. |
| Manifest residual refraction | 12 months postoperatively | To compare SPH between groups implanted with 690AD and 690ADY monofocal IOLs 12 months after IOL implantation. CYL and axis are not applicable, as the investigational- and comparator devices are monofocal IOLs, that do not correct astigmatism. |
| Patient satisfaction | 12 months postoperatively | Visual Function Questionnaire 25 (National Eye Institute) is used to evaluate overall satisfaction, subjective perception of colour and scotopic vision at 12 months postoperatively. The results are evaluated according to the official evaluation guide. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety outcomes - Complications of IOL implantation | Month12 postoperatively | Complications of IOL implantation * Posterior capsular opacification (PCO) * Opacification, IOL discoloration |
| Safety outcomes - Postoperative complications | Month1 postoperatively | Postoperative complications of cataract surgery * Cystoid macular oedema * Iris abnormalities * Corneal oedema * Wound leak or rupture * IOL dislocation, removal, or exchange * Inflammation (Endophthalmitis, anterior chamber cells, anterior chamber flare, hypopyon) * Retinal tear, break, or detachment * Persistent iritis * Elevated intraocular pressure * Pupillary block * Cornea status |
| Safety outcomes - Intraoperative complications | Day1 postoperatively | Intraoperative complications of cataract surgery * Posterior capsular or zonular rupture * Vitreous loss/anterior vitrectomy or aspiration * Iris/ciliary body injury * Loss of nuclear material into vitreous * Suprachoroidal haemorrhage * Retrobulbar haemorrhage |
Countries
Hungary
Outcome results
None listed