Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation With Extended Patient Enrolment
NCT Number: NCT06578923
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cataract|Pseudophakia|Intraocular Lens Complication|Intraocular Lens Opacification
Interventions: DIAGNOSTIC_TEST: Standard of care|BEHAVIORAL: Patient satisfaction questionnare
Sponsor: Medicontur Medical Engineering Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-15
Completion Date: 2024-05-03
Locations: Szabolcs-Szatmár-Bereg Vármegyei Kórházak és Egyetemi Oktatókórház, Szemészeti Klinika, Nyíregyháza, 4400, Hungary|Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika, Pécs, 7623, Hungary

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

Primary Outcome Measures: 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., 12 months postoperatively
Secondary Outcome Measures: 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., 12 months postoperatively|UDVA and CDVA, 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., 12 months postoperatively|Manifest residual refraction, 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., 12 months postoperatively|Patient satisfaction, 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., 12 months postoperatively
Other Outcome Measures: Safety outcomes - Intraoperative complications, 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, Day1 postoperatively|Safety outcomes - Postoperative complications, 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, Month1 postoperatively|Safety outcomes - Complications of IOL implantation, Complications of IOL implantation

* Posterior capsular opacification (PCO)
* Opacification, IOL discoloration, Month12 postoperatively