Ocular Surface Disease in Glaucoma Patients on Long-Term Therapy
Prevalence and Severity of Ocular Surface Disease Among Adult Patients With Glaucoma on Long-Term Topical Antiglaucoma Medications
This cross-sectional study aims to determine the prevalence and severity of ocular surface disease among adult patients with glaucoma receiving long-term topical antiglaucoma medications.
調査の概要
詳細な説明
Long-term use of topical antiglaucoma medications may adversely affect the ocular surface. This observational study will include adult patients with glaucoma who have been using one or more topical antiglaucoma medications for at least 6 months.
Participants will complete the Ocular Surface Disease Index (OSDI) questionnaire and undergo clinical ocular surface assessment including tear film break-up time, Schirmer I test, and corneal fluorescein staining.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Margo f Awad, Resident
- 電話番号：+20 12 73302611
- メール：margo19.mahros@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adult patients with diagnosed glaucoma receiving long-term topical antiglaucoma medications at Assiut University Hospital and El Mabarra Hospital.
説明
Inclusion Criteria:
- - Age 18 years or older
- Diagnosed glaucoma
- Currently receiving one or more topical antiglaucoma medications
- Duration of topical antiglaucoma treatment ≥6 months
- Written informed consent
Exclusion Criteria:
- - Current use of concomitant topical ocular medication that may affect the ocular surface (e.g., topical cyclosporine)
- Previous ocular surgery within the preceding 6 months
- History of corneal surgery or significant ocular trauma affecting the ocular surface
- Active ocular infection or significant active ocular inflammation
- Contact lens wear
- Systemic autoimmune or connective tissue diseases known to affect the ocular surface (e.g., Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus)
- Significant corneal pathology interfering with ocular surface assessment
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_ONLY
- 時間の展望：CROSS_SECTIONAL
コホートと介入
グループ/コホート |
|---|
|
Single cohort: Glaucoma patients on long-term topical therapy
Adult patients with glaucoma receiving topical antiglaucoma medications for at least 6 months who will undergo OSDI questionnaire and clinical ocular surface assessment. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prevalence of ocular surface disease
時間枠：Baseline
|
Proportion of patients with ocular surface disease defined as an Ocular Surface Disease Index (OSDI) score ≥13. |
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Patients with Mild Ocular Surface Disease Symptoms
時間枠：Baseline
|
Proportion of patients with mild ocular surface disease symptoms defined as OSDI score 13-22. |
Baseline
|
|
Proportion of Patients with Moderate Ocular Surface Disease Symptoms
時間枠：Baseline
|
Proportion of patients with moderate ocular surface disease symptoms defined as OSDI score 23-32. |
Baseline
|
|
Proportion of Patients with Severe Ocular Surface Disease Symptoms
時間枠：Baseline
|
Proportion of patients with severe ocular surface disease symptoms defined as OSDI score 33-100. |
Baseline
|
|
Mean OSDI score
時間枠：Baseline
|
Mean Ocular Surface Disease Index score (range 0-100). |
Baseline
|
|
Tear film break-up time (TBUT)
時間枠：Baseline
|
Mean tear film break-up time in seconds. |
Baseline
|
|
Schirmer I test result
時間枠：Baseline
|
Mean Schirmer I test value in millimeters. |
Baseline
|
|
Corneal fluorescein staining score
時間枠：Baseline
|
Mean total corneal fluorescein staining score (range 0-15) according to the NEI/Industry Workshop grading scale. |
Baseline
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Mohamed s Abdel-rehim, prof、Ophthalmology Department, Assiut University Hospitals
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。