The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients
The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients.
To investigate if the Eye Drop Guide more effective than carefully instructed routine technique for chronic glaucoma patients to self-instill eye drops.
And what factors are associated with the failure of self-instillation eye drops with the Eye Drop Guide?
調査の概要
状態
詳細な説明
The participants are randomized into 2 groups. For group I; the participants will be instructed to use the Eye Drop Guide first while for group II; the participants will be instructed to use the routine self-instillation technique first. The instruction will be given to all participants by the same investigator. The participants are allowed to practice until confidence in the techniques to which they are assigned. The participants then are instructed to use only that technique to instill eye drops in both eyes every day and keep the diary to document the date, time of practice, and number of bottles use in each eye for practice at home. The investigators make a telephone visit at 1 week to remind the practice routine and the follow up schedule. The 2 week follow up will be scheduled to evaluate the self-instillation performance using the techniques to which they are assigned by the VDO recordings under the same setting as Day 1.
After VDO recordings the participants will be switched to receive the other technique with the same instruction as the other group. Allow the same period of practice in the hospital and at home. The investigators again will make a 1-week telephone visit and 2-week follow up after self-practice at home. At week 4 the VDO recordings of self-instillation performance will be taken again under the same setting as previous records.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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Bangkok、タイ、10700
- 募集
- Faculty of medicine, Siriraj hospital, Mahidol university
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コンタクト：
- Darin Sakiyalak, MD
- 電話番号：6624198033-4
- メール：darin.sak@mahidol.ac.th
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主任研究者：
- Darin Sakiyalak, MD
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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
説明
Inclusion Criteria:
- Have been diagnosed of chronic glaucoma for 3 months or longer
- Age of 18 years or over
- Self-administer eye drops regularly
Exclusion Criteria:
- Perioperative patients
- Patients who were blind from other diseases
- Patients with ophthalmic conditions that affect the eye drop instillation e.g. nystagmus, ptosis, exophthalmos, enophthalmos, microphthalmos, symblepharon, restrictive ophthalmoplegia
- Patients whose underlying conditions would affect the patient's adherence to the protocol e.g. dementia, psychosis, mental retardation, neurological conditions resulting in tremor or paralysis, rheumatoid arthritis, hand deformities
- Patients who are allergic to artificial tears eye drop
- Patients who are not able to return for the follow-up schedule
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Routine self-instillation technique
The participants first use the Routine self-instillation technique for two weeks and then switch to the Eye Drop Guide technique for another two weeks.
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For the non-seeing eye (best-corrected visual acuity ≤ 20/400) the participants should insert the bottle in the device before cover the eye then proceed with head tilt and look upward. |
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実験的：Eye Drop Guide technique
The participants first use the Eye Drop Guide technique for two weeks and then switch to the Routine self-instillation technique for another two weeks.
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For the participants using more than one medication after instilling one bottle the participants should wait 3-5 minutes between administering different medications in the same eye. |
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 |
時間枠 |
|---|---|
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To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide.
時間枠：1 month
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1 month
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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1. To compare the total number of drops dispensed and time to instill drop between 2 groups.
時間枠：1 month
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1 month
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2. To identify the factors that associated with failure of using the Eye Drop Guide.
時間枠：1 month
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1 month
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Darin Sakiyalak, MD、Mahidol University
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 440/2555 (EC4)
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