Personality Traits and Their Relation to Ocular Adverse Effects From Glaucoma Medications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Difference in Five-Factor Model neuroticism scores between participants with and without significant ocular adverse reactions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
Participants without a documented significant ocular adverse effect resulting in medication discontinuation.
干预措施: No Interventions (Other)
Case
Participants with at least one documented ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication.
干预措施: No Interventions (Other)
结局指标
主要结局
Difference in Five-Factor Model neuroticism scores between participants with and without significant ocular adverse reactions
时间窗: Assessed once during the single study session, lasting approximately 30 minutes.
Neuroticism will be measured using the neuroticism domain of the Five-Factor Model personality questionnaire. Mean neuroticism scores will be compared between: Cases: participants who experienced at least one ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication. Controls: participants who did not experience a significant ocular adverse effect resulting in medication discontinuation. Higher neuroticism scores indicate a higher level of the neuroticism personality trait.
次要结局
未报告次要终点
研究者
hady.saheb
Associate Professor of Ophthalmology
McGill University Health Centre/Research Institute of the McGill University Health Centre
