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Идёт набор NCT06731530

Corneal Biomechanics, Optical Properties and Anterior Segment Structural Features in Patients With Pseudoexfoliation

Наблюдательное Pseudoexfoliation Syndrome Biomechanical Parameters Corneal Densitometry

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pentacam-AXL, HD Analyzer, Corvis ST, OCT-A Angiovue.
Кому может быть актуально
Состояния в реестре: Pseudoexfoliation Syndrome, Biomechanical Parameters, Corneal Densitometry. Базовые параметры: 60 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Греция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Comparative Study of Anterior Segment Structural Features, Biomechanical Behaviour and Optical Properties of the Cornea in Patients With and Without Pseudoexfoliation Syndrome.

Обзор

The purpose of this study is to assess the effect of pseudoexfoliation syndrome on corneal biomechanics, optical clarity of the cornea, and anterior segment structural features.

Подробное описание

A case group of patients with pseudoexfoliation syndrome will ungergo examinations to evaluate corneal optical properties (Pentacam-AXL, HD analyzer), biomechanics (Corvis ST) and anterior segment structural features (OCT-A Angiovue, Pentacam-AXL, IOLMaster V.5.4, Topcon SP-1P). The same examinations will be performed on a group of age-matched controls, and the results will be compared.

Corneal optical density will be assessed by backscatter measurement (COD, corneal optical density) using Pentacam AXL (Oculus, Wetzlar, Germany).

Corneal optical density will also be assessed by forward-scatter measurement (OSI, objective scatter index) using HD Analyzer (Visiometrics, Terassa, Spain, Keeler). The level of agreement between the two optical density indicators (OSI, COD) will be evaluated.

Corneal biomechanics measurements will be performed using Corvis Scheimpflug Technology. The main biomechanical parameter of the Corvis ST is DA (deformation amplitude). DA quantifies how the cornea deforms in response to an air puff and helps evaluate corneal stiffness and elasticity.

An additional objective is the study of structural parameters of the cornea as well as, more broadly, the anterior segment in pseudoexfoliation syndrome (PEX) patients, aiming to understand and describe the effects of PEX with the highest possible accuracy. Specifically, using the Pentacam-AXL (Oculus, Wetzlar, Germany), the IOLMaster V.5.4 (Carl Zeiss Meditec), the OCT-Angiography Angiovue (Optovue, Inc., Fremont, California, USA), and the specular microscope Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan), a comparative study will be conducted across a range of variables and maps: corneal topographic data, keratometric measurements, curvature radius data, pachymetric data, anterior chamber depth and volume, angle width, axial length, pupil diameter, and endothelial cell density. Some of these data, such as central corneal thickness, can be measured by two of the aforementioned devices. In this case, we will also attempt to evaluate the level of agreement between the two devices.

Вмешательства

  • Устройство Pentacam-AXL
    Pentacam-AXL (Oculus, Wetzlar, Germany)
  • Устройство HD Analyzer
    HD Analyzer (Visiometrics, Terassa, Spain, Keeler)
  • Устройство Corvis ST
    Corvis ST (Oculus, Germany)
  • Устройство OCT-A Angiovue
    OCT-A Angiovue (Optovue, Inc., Fremont, California, USA)
  • Устройство IOLMaster V.5.4
    IOLMaster V.5.4 (Carl Zeiss., Meditec)
  • Устройство Topcon SP-1P
    Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan)
  • Другое BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus examination
    BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus Examination

Первичные конечные точки

  • Corneal optical density assessed by backscatter measurement [Срок оценки: Baseline, during examination : approx. 1 hour]
  • Corneal optical density assessed by forward-scatter measurement [Срок оценки: Baseline, during examination : approx. 1 hour]
Вторичные конечные точки (6)
  • Corneal biomechanics using Corvis Scheimpflug Technology [Срок оценки: Baseline, during examination : approx. 1 hour]
  • Optical quality measured by HD-analyzer : Strehl ratio [Срок оценки: Baseline, during examination : approx. 1 hour]
  • Optical quality measured by HD-analyzer : MTF cut-off [Срок оценки: Baseline, during examination : approx. 1 hour]
  • Corneal biomechanics using Corvis Scheimpflug Technology : velocity [Срок оценки: Baseline, during examination : approx. 1 hour]
  • Corneal biomechanics using Corvis Scheimpflug Technology : length [Срок оценки: Baseline, during examination : approx. 1 hour]
  • Corneal biomechanics using Corvis Scheimpflug Technology : bIOP [Срок оценки: Baseline, during examination : approx. 1 hour]

Критерии участия

Критерии включения

  • age 60-80 years.
  • unilateral or bilateral pseudophakia (cataract surgery undergone at Papageorgiou General Hospital, Thessaloniki, Greece).
  • open anterior chamber angle (grade > 2, van Herick method).

Критерии исключения

  • History of intraocular surgery other than uncomplicated cataract surgery (phakoemulsification).
  • Cataract surgery within the last 3 months.
  • History of ocular trauma.
  • Use of contact lenses.
  • Corneal pathology.
  • Use of anti-VEGF medications.
  • History of uveitis or active uveitis.
  • Hypertension (IOP > 21 mmHg) or glaucoma.
  • Myopia or hyperopia greater than 3 diopters.
  • Astigmatism greater than 1.5 diopters.
  • Posterior capsular opacification grade 2, 3, or 4 based on the EPCO grading scale.
  • Tear break-up time <10 sec

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Греция · 1 центр
  • 2nd Department of Ophthalmology, Papageorgiou General Hospital — Thessaloniki

Идентификаторы

NCT: NCT06731530 · 36661

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗