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.

ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Diagnosis of glaucoma.

Current or previous treatment with one or more glaucoma medications.

Able to provide informed consent.

Disqualifiers

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.

Trial population

Approximately 352 adults with glaucoma who are currently receiving or have previously received treatment with one or more glaucoma medications will be recruited from the McGill Academic Eye Centre and the Lachine Hospital Ophthalmology Clinic. Participants will be classified into two groups: Cases: Participants with at least one documented ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication. Controls: Participants without a documented significant ocular adverse effect resulting in medication discontinuation. Approximately 176 participants will be included in each group

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • No Interventions

    Other intervention

    There is no intervention

Treatment groups

352 Participants
are divided into 2 treatment groups
Group A: Case1 intervention
Group B: Control1 intervention

Trial outcomes

Primary outcomes

1

Difference in Five-Factor Model neuroticism scores between participants with and without significant ocular adverse reactions

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.

Time frame
Assessed once during the single study session, lasting approximately 30 minutes.

Secondary outcomes

Other outcomes

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