Quality of Life In Patients With Allergic Conjunctivitis In Treatment With Sublingual Allergen Immunotherapy In A Referral Ophthalmological Hospital

N/AActive Not RecruitingNCT07149298

Instituto de Oftalmología Fundación Conde de Valenciana100 enrolled

Overview

The goal of this observational study is to evaluate both clinical changes and quality-of-life outcomes in patients with allergic conjunctivitis treated with allergen-specific immunotherapy, integrating objective clinical parameters and validated quality-of-life measures to obtain a comprehensive view of the therapeutic impact.

BACKGROUND: Allergic conjunctivitis (AC) is an inflammatory disease of the ocular surface that may be affecting people's quality of life. Studies have shown that allergic diseases are a risk factor for depression, sleep problems, and affect the patient's mood. Allergen-specific sublingual immunotherapy has been shown to be beneficial for the treatment of asthma and allergic rhinitis. JUSTIFICATION: There are no studies demonstrating whether allergen-specific sublingual immunotherapy improves the different dimensions of quality of life affected by allergic conjunctivitis. HYPOTHESIS: Quality of life in allergic conjunctivitis will improve with the administration of allergen-specific sublingual immunotherapy. GENERAL OBJECTIVE: To define changes in quality of life in patients with allergic conjunctivitis before, during, and after allergen-specific sublingual immunotherapy using a standardized quality of life questionnaire at an ophthalmology referral hospital. MATERIAL AND METHODS: A retrospective, observational, and longitudinal study will be conducted, reviewing 100 patient records of patients who attended the Immunology Department of the Conde de Valenciana Institute from 2018 to 2023, diagnosed with conjunctivitis, treated with allergen-specific sublingual immunotherapy, completed all 3 years of treatment, and completed at least 8 quality of life questionnaires.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Allergic Conjunctivitis of Both Eyes

Eligibility

Sex: ALLMin age: 6 YearsMax age: 86 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient records containing complete information * Both sexes * Age range: 6 to 86 years * Between 2018 and 2023 * Diagnosed with allergic conjunctivitis * Who have received treatment with allergen-specific sublingual immunotherapy * With 8 assessments from the immunology and cornea department * With 7 quality of life questionnaires completed by the patient Exclusion Criteria: * Patient records for other inflammatory ocular conditions * Those with chronic diseases * Those who have received naturopathic or immunomodulatory treatment during the follow-up period for allergen-specific sublingual immunotherapy

Locations (1)

Instituto de Oftalmología FAP Conde de Valenciana

Mexico City, Mexico

Outcomes

Primary Outcomes

Quality of life evaluated by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico in patients with Allergic Conjunctivitis treated with sublingual allergen immunotherapy.

To evaluate the quality of life in patients with Allergic Conjunctivitis treated with sublingual allergen immunotherapy using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico. This questionnaire features 28 items grouped in 7 domains: activities, sleep, other symptoms, practical problems, nasal symptoms, eye symptoms, emotional. For each item, the minimum score is 0 and the maximum score is 6. After the questionnaire is completed, a mean score is calculated. A higher overall score indicates a poorer quality of life.

Time frame: Before Sublingual Immunotherapy

Quality of life in patients with Allergic Conjunctivitis treated with sublingual allergen immunotherapy evaluated using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico.

To evaluate the quality of life in patients with Allergic Conjunctivitis during 6 months of sublingual allergen immunotherapy using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico. This questionnaire features 28 items grouped in 7 domains: activities, sleep, other symptoms, practical problems, nasal symptoms, eye symptoms, emotional. For each item, the minimum score is 0 and the maximum score is 6. After the questionnaire is completed, a mean score is calculated. A higher overall score indicates a poorer quality of life.

Time frame: From enrollment to the end of the 6th month of Allergen Immunotherapy treatment

Quality of life in patients with Allergic Conjunctivitis treated with sublingual allergen immunotherapy using Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico.

To evaluate quality of life in patients with Allergic Conjunctivitis after completing allergen-specific sublingual immunotherapy using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico. This questionnaire features 28 items grouped in 7 domains: activities, sleep, other symptoms, practical problems, nasal symptoms, eye symptoms, emotional. For each item, the minimum score is 0 and the maximum score is 6. After the questionnaire is completed, a mean score is calculated. A higher overall score indicates a poorer quality of life.

Data from ClinicalTrials.gov

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