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 September 2021 - March 2022. 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
OTHERStandard of care
12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.
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
Healthy volunteers
No
Inclusion criteria
* Adult males or females above 18 years of age; * Pseudophakic patients implanted with 690AD or 690ADY monofocal IOLs (implanted between September 2021 - March 2022); * 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 \> 1.0 diopter * 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 |
|---|---|---|
| CDVA | 12 months postoperatively | Monocular corrected distance visual acuity (CDVA) 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 |
|---|---|---|
| Spherical Equivalent | 12 months postoperatively | Spherical Equivalent shall be used to calculate manifest residual refraction. To compare sphere, cylinder and axis of the eye between groups implanted with 690AD and 690ADY monofocal IOLs 12 months after IOL implantation. |
| Patient satisfaction | 12 months postoperatively | Subjective perception of colour perception and scotopic vision shall be assessed by interviewing the patient using visual function questionnaire (VFQ-25 questionnaire) . To compare overall satisfaction, subjective perception of colour perception and scotopic vision between groups implanted with 690AD and 690ADY, postoperatively at 12 months. |
| Cylinder | 12 months postoperatively | Cylinder shall be used to calculate manifest residual refraction. |
| Axis of the eye | 12 months postoperatively | Axis of the eye shall be used to calculate manifest residual refraction. |
| UDVA | 12 months postoperatively | Monocular uncorrected distance visual acuity (UDVA) To compare monocular uncorrected distance visual acuity (UDVA) between groups implanted with 690AD and 690ADY monofocal IOLs 12 months postoperatively. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications of IOL implantation | at Month12 postoperatively | To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria. |
| Intraoperative complications of cataract surgery | at Day1 postoperatively | To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria. |
| Postoperative complications of cataract surgery | at Month1 postoperatively | To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria. |
Countries
Hungary
Outcome results
None listed