Effect of Dry Eye Treatment on Corneal Astigmatism Measurements
Effect of Dry Eye and Ocular Surface Treatment on Agreement and Repeatability of Corneal Astigmatism Measurements Among Three Devices
This prospective single-center study evaluates the effect of dry eye disease and short-term ocular surface treatment on the agreement and repeatability of corneal astigmatism measurements in patients with age-related cataract. Participants undergoing preoperative cataract evaluation are classified into a control group or a dry eye disease group according to ocular surface symptoms and objective tear film findings.
All participants undergo ocular surface assessment and repeated corneal measurements using three commonly used devices: IOLMaster 700, Pentacam AXL, and iTrace Prime. Measurements include keratometric corneal astigmatism, total corneal astigmatism, and vector components of astigmatism. Patients with dry eye disease receive 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, after which ocular surface assessment and device measurements are repeated.
The primary objective is to determine whether dry eye disease reduces interdevice agreement and test-retest repeatability of corneal astigmatism measurements, and whether short-term ocular surface treatment improves measurement stability. Interdevice agreement is assessed using Bland-Altman analysis, and repeatability is evaluated using within-subject standard deviation, test-retest repeatability, and intraclass correlation coefficient.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Baoxian Zhuo
- メール：1532483480@qq.com
研究連絡先のバックアップ
- 名前：Xuanqiao Lin, Doctor
- 電話番号：+8615088920668
- メール：1532483480@qq.com
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200000
- 募集
- Eye and ENT Hospital of Fudan University
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コンタクト：
- Xuanqiao Lin
- 電話番号：15088920668
- メール：1532483480@qq.com
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients with age-related cataract undergoing preoperative ocular examination.
- Ability to complete ocular surface evaluation, including the Ocular Surface
- Disease Index questionnaire, non-invasive tear film break-up time, tear meniscus height, Schirmer test, and ocular surface staining.
- Ability to complete repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime.
- Ability to maintain stable fixation during device measurements. Provision of written informed consent.
Exclusion Criteria:
- Previous ocular surgery or ocular trauma.
- Corneal degeneration, corneal dystrophy, or other corneal diseases that could affect corneal measurements.
- Active corneal or conjunctival infection.
- Uveitis.
- Use of any topical eye drops within 24 hours before examination.
- Use of antiglaucoma medications.
- Contact lens wear within 1 month before examination.
- Previous or ongoing treatment for dry eye disease.
- Poor fixation during device measurements.
- Poor-quality measurements from any study device
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control Cohort
Patients with age-related cataract who did not meet the diagnostic criteria for dry eye disease.
Participants underwent ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime.
No ocular surface treatment was administered in this cohort.
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実験的：Dry Eye Disease Cohort
Patients with age-related cataract who met the diagnostic criteria for dry eye disease.
Participants underwent baseline ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime.
They then received 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, followed by repeat ocular surface evaluation and device measurements using the same protocol.
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0.3% sodium hyaluronate eye drops administered four times daily for 2 weeks in participants with dry eye disease.
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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 |
|---|---|---|
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Interdevice Agreement of Corneal Astigmatism Measurements
時間枠：Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
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Interdevice agreement of corneal astigmatism measurements among IOLMaster 700, Pentacam AXL, and iTrace Prime will be assessed using Bland-Altman analysis.
Pairwise comparisons will be performed for IOLMaster 700 versus Pentacam AXL, IOLMaster 700 versus iTrace Prime, and Pentacam AXL versus iTrace Prime.
The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45.
The mean difference and 95% limits of agreement will be calculated.
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Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
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Test-Retest Repeatability of Corneal Astigmatism Measurements
時間枠：Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
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Test-retest repeatability of corneal astigmatism measurements obtained using IOLMaster 700, Pentacam AXL, and iTrace Prime will be evaluated using three consecutive valid measurements from each device.
The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45.
Repeatability will be assessed using within-subject standard deviation, test-retest repeatability calculated as 2.77 times the within-subject standard deviation, and intraclass correlation coefficient with 95% confidence intervals.
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Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Xuanqiao Lin, Doctor、Fudan University
研究記録日
主要日程の研究
研究開始 (実際)
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
本研究に関する用語
その他の研究ID番号
- DryEye-2026-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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