Меню
Идёт набор NCT07739784

This Study Examines Whether Personality Traits Influence the Frequency or Severity of Ocular Adverse Effects Reported by Patients Using Glaucoma Medications. The Findings May Identify Patients at Greater Risk of Intolerance and Support More Personalized Treatment and Counselling.

Наблюдательное Glaucoma

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: No Interventions.
Кому может быть актуально
Состояния в реестре: Glaucoma. Базовые параметры: от 18 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Personality Traits and Their Relation to Ocular Adverse Effects From Glaucoma Medications

Обзор

The goal of this observational study is to learn whether personality traits are related to eye side effects from glaucoma medications in adults who currently use or previously used these medications. The main questions this study aims to answer are: Are certain personality traits associated with the occurrence or severity of eye side effects from glaucoma medications? Do personality traits differ between people who experience these side effects and those who do not? Participants will complete a questionnaire that measures five personality traits: openness, conscientiousness, extraversion, agreeableness, and neuroticism. They will also provide basic demographic information. The researchers will review participants' medical records to collect information about their glaucoma medications and any related eye side effects, including the type and frequency of side effects and whether treatment was changed because of them. Participation involves one session lasting approximately 30 minutes. Questionnaires may be completed securely online or in person at the clinic. The study will include approximately 352 adults. No treatment will be assigned or changed as part of this study.

Подробное описание

Glaucoma is a chronic eye disease that can cause irreversible vision loss. Lowering intraocular pressure is the principal strategy used to reduce the risk of disease progression. Topical medications are commonly used as first-line or adjunctive treatment, either alone or in combination with laser or surgical therapy. Although effective, glaucoma medications may cause ocular adverse effects such as dryness, irritation, redness, allergic reactions, inflammation, eyelash growth, changes in iris or periocular skin pigmentation, and changes in the tissues surrounding the eye. These adverse effects may affect comfort, adherence to treatment, and the need to modify or discontinue therapy.

The type and severity of adverse effects vary considerably among individuals. This variability may be related to the medication used, its preservatives, the duration of treatment, patient characteristics, or differences in how symptoms are perceived and reported. Personality traits may influence a person's awareness, interpretation, reporting, and tolerance of medication-related symptoms. However, the possible relationship between personality traits and ocular adverse effects from glaucoma medications has not been well studied.

The primary objective of this observational study is to evaluate the relationship between personality traits and ocular adverse effects in adults who are currently being treated, or were previously treated, with one or more glaucoma medications. The study will examine whether particular personality traits are associated with the occurrence and severity of ocular adverse effects. It will also compare the personality profiles of participants who have experienced specified medication-related ocular adverse effects with those of participants who have not.

Personality will be assessed using a questionnaire based on the Five-Factor Model. This widely used model describes personality across five domains: openness, conscientiousness, extraversion, agreeableness, and neuroticism. The study will investigate whether scores in these domains are associated with the type, frequency, or severity of ocular adverse effects and with treatment changes made because of these effects.

Approximately 352 adults aged 18 years or older will be recruited. Eligible participants must have a diagnosis of glaucoma and must currently be using, or have previously used, at least one glaucoma medication. Individuals with serious anxiety or depression that was present before the initiation of glaucoma treatment will not be eligible, as these conditions may affect the assessment of personality traits or the reporting of medication-related symptoms.

This is an observational case-control study. Participants will not be assigned to a treatment, and their glaucoma care will not be changed as part of the research. Participants who have experienced ocular adverse effects related to glaucoma medications will be compared with participants who have not experienced the adverse effects of interest.

Participation will involve one study session lasting approximately 30 minutes. The session may be completed remotely through Qualtrics, a secure web-based survey platform, or in person at the McGill Academic Eye Centre, according to the participant's preference. Questionnaires will be available in English and French.

During the study session, participants will complete the Five-Factor Model personality questionnaire by rating their agreement or disagreement with statements about their usual thoughts, feelings, and behaviours. Participants will also complete a brief demographic questionnaire that collects information such as age, gender, and ethnicity.

The research team will review relevant information from participants' medical records. Information collected will include the glaucoma medications used, medication type, dosage, duration of treatment, documented ocular adverse effects, the type and frequency of these effects, and any related changes to treatment. Questionnaire responses will be analyzed together with the clinical information to identify possible associations between personality traits and medication-related ocular adverse effects.

The study does not involve an experimental medication, additional clinical testing, or any change to the participant's usual treatment. There is no expected direct medical benefit to participants. The principal foreseeable risk is a potential breach of confidentiality. Participants will be identified in the research database by a study code, and identifying information will be stored separately from study data. Study information will be retained for seven years and may be presented at scientific meetings or published in scientific journals in a form that does not identify individual participants.

The findings may improve understanding of why patients differ in their experience and reporting of glaucoma medication side effects. If meaningful associations are identified, the results could support future research into more individualized approaches to medication counselling, monitoring, treatment selection, and management of adverse effects.

Вмешательства

  • Другое No Interventions
    There is no intervention

Первичные конечные точки

  • Difference in Five-Factor Model neuroticism scores between participants with and without significant ocular adverse reactions [Срок оценки: Assessed once during the single study session, lasting approximately 30 minutes.]

Критерии участия

Критерии включения

  • Age 18 years or older.
  • Diagnosis of glaucoma.
  • Current or previous treatment with one or more glaucoma medications.
  • Able to provide informed consent.
  • Able to complete the study questionnaires in English or French.

Критерии исключения

  • Uncontrolled anxiety or depression that was present before glaucoma medication treatment began.
  • Unable to provide informed consent.
  • Unable to complete the study questionnaires in English or French.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Канада · 1 центр
  • McGill University Health Center — Montreal

Публикации

  • Inoue K. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014 May 12;8:903-13. doi: 10.2147/OPTH.S44708. eCollection 2014. PMID 24872675
  • Gazzard G, Konstantakopoulou E, Garway-Heath D, Adeleke M, Vickerstaff V, Ambler G, Hunter R, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial: Six-Year Results of Primary Selective Laser Trabeculoplasty versus Eye Drops for the Treatment of Glaucoma and Ocular Hypertension. Ophthalmology. 2023 Feb;130(2):139-151. doi: 10.1016/j.ophtha PMID 36122660
  • Davis C, Ralevski E, Kennedy SH, Neitzert C. The role of personality factors in the reporting of side effect complaints to moclobemide and placebo: a study of healthy male and female volunteers. J Clin Psychopharmacol. 1995 Oct;15(5):347-52. doi: 10.1097/00004714-199510000-00007. PMID 8830066
  • Dahl AA, Smedsland SK, Vandraas KF, Bohn SK, Falk RS, Kiserud CE, Reinertsen KV. High neuroticism is associated with common late adverse effects in a nationwide sample of long-term breast cancer survivors. Breast Cancer Res Treat. 2023 Nov;202(1):97-104. doi: 10.1007/s10549-023-07055-2. Epub 2023 Aug 1. PMID 37528264
  • Baudouin C. Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. Acta Ophthalmol. 2008 Nov;86(7):716-26. doi: 10.1111/j.1755-3768.2008.01250.x. Epub 2008 Jun 3. PMID 18537937

Идентификаторы

NCT: NCT07739784 · 2026-10903

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗