An observational study in Cataract and Pseudophakia, sponsored by Medicontur Medical Engineering Ltd. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by Medicontur Medical Engineering Ltd · Observational
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:
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 80 is below the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Medicontur Medical Engineering Ltd is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia), who have undergone monocular or binocular implantation with the 640AD IOL model.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with the following condition(s) at the time of the baseline visit:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly
Diagnostic Test: Standard of care · Other: Patient satisfaction questionnare
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.
Monocular corrected distance visual acuity (CDVA)
To compare monocular corrected distance visual acuity (CDVA) between 12 months postoperative and preoperative results.
Time frame: 12 months postoperatively
Monocular uncorrected distance visual acuity (UDVA)
To compare monocular uncorrected distance visual acuity (UDVA) at 12 months postoperative and preoperative status.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 12 months postoperatively
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
Time frame: 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
Time frame: Month1 postoperatively
Safety outcome - Complications of IOL implantation
Complications of IOL implantation * Posterior capsular opacification (PCO) * Opacification, IOL discoloration
Time frame: Month12 postoperatively
Ran from May 2023 to primary completion in Apr 2024, 11 months.
Of 67 industry-sponsored observational studies under Cataract, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 11 months is below that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Medicontur Medical Engineering Ltd