Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
NCT Number: NCT06578910
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cataract|Pseudophakia
Interventions: DIAGNOSTIC_TEST: Standard of care|OTHER: Patient satisfaction questionnare
Sponsor: Medicontur Medical Engineering Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-23
Completion Date: 2024-04-25
Locations: SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika, Szeged, 6720, Hungary

Summary:
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is 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 640AD IOLs mono- or binocularly between December 2021 - December 2022.

Data from five visits will be collected:

* Baseline preoperative (maximum 30 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 12 months postoperative and preoperative results., 12 months postoperatively
Secondary Outcome Measures: Monocular uncorrected distance visual acuity (UDVA), To compare monocular uncorrected distance visual acuity (UDVA) at 12 months postoperative and preoperative status., 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 at 12 months postoperative and preoperative status., 12 months postoperatively|Manifest residual refraction, To compare residual SPH at 12 months postoperative and preoperative status. (Residual CYL and axis are not applicable, as it is a monofocal IOL, that does 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 perception and scotopic vision at 12 months postoperatively. The results are evaluated according to the official evaluation guide., 12 months postoperatively
Other Outcome Measures: Safety outcome - 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 outcome - 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 outcome - Complications of IOL implantation, Complications of IOL implantation

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