Toric Performance And Constant Evaluation

Официальное название

Prospective Assessment of Constant Optimization and Visual Outcomes Following Monofocal Toric IOL Implantation

Обзор

The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.

Вмешательства

• Устройство Monofocal toric IOL
  The device under investigation is a CE-approved monofocal bitoric, aspheric, aberration-correcting intraocular lens indicated for aphakia after surgical extraction of the cataractous natural lens and is also indicated for the correction of regular corneal astigmatism.

Первичные конечные точки

• Refractive predictability [Срок оценки: From preoperative visit to the final postoperative visit at twelve months]

Вторичные конечные точки (12)

• Refractive outcomes [Срок оценки: From preoperative visit to the final postoperative visit at twelve months]
• Refractive predictability [Срок оценки: From preoperative visit to the final postoperative visit at twelve months]
• Reduction in cylindrical power [Срок оценки: From preoperative visit to the final postoperative visit at twelve months]
• IOL Rotation [Срок оценки: From preoperative visit to the final postoperative visit at twelve months]
• Stability of IOL axis orientation [Срок оценки: Between 30 to 60 days and 120 to 180 days]
• Axis Misalignment [Срок оценки: From baseline to postoperative visit 120-180 days]
• Monocular Uncorrected Distance Visual Acuity (UDVA) [Срок оценки: 12-Month Postoperative]
• Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better [Срок оценки: 12-Months Postoperatively]
• Monocular Best-Corrected Distance Visual Acuity (CDVA) [Срок оценки: 12-Months Postoperatively]
• Monocular Uncorrected Intermediate Visual Acuity (UIVA) [Срок оценки: 12-Months Postoperatively]
• Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) [Срок оценки: 12-Months Postoperatively]
• Monocular (1st eye implantations) defocus curve [Срок оценки: 12-Months Postoperatively]

Критерии участия

Критерии включения

• Aged 18 years or older;
• Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits;
• Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral phacoemulsification or Femtosecond-Laser-Assisted cataract surgery;
• Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated.
• Signed informed consent form;
• Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment;
• Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps);
• Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm;
• Clear intraocular media other than cataract.

Критерии исключения

• Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject;
• Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye
• Traumatic cataract;
• Pregnancy or lactation;
• Concurrent participation in another drug or device investigation within the last 30 days;
• Irregular astigmatism;
• Instability of keratometry or biometry measurements;
• Subjects wearing contact lenses as standard vision aid;
• Abnormal pupil;
• Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.);
• History of concurrent intraocular inflammation;
• Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies);
• History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis;
• Pseudoexfoliation syndrome (according to investigator judgement);
• Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
• All kind of infections (acute ocular disease, external / internal infection, systemic infection);
• Monophthalmic patient;
• Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease
• Patient expected to require retinal laser treatment before the end of the last follow-up examination;
• Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination;
• Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy)
• In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 2 центра

• Oční klinikaO — Prague
• Oční Centrum Praha — Prague

Германия · 2 центра

• Universitätsklinikum Heidelberg — Heidelberg
• PVK Precise Vision GmbH — Rheine

Испания · 1 центр

• Ofatlivist Alicante — Alicante

Великобритания · 1 центр

• Ayrshire Eye Clinic — Ayr

Идентификаторы

NCT: NCT07471295 · GPAS-SAS-026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗