Night Driving After Trifocal Versus Monofocal IOL Implantation (TriIOL)
2026年8月5日 更新者：Jin Yang
Night-Driving Visual Quality and Visual Disturbances After Bilateral Trifocal Versus Monofocal Intraocular Lens Implantation: A Prospective Observational Cohort Study
This prospective observational cohort study will compare night-driving visual difficulty and visual disturbances after bilateral implantation of an Alcon trifocal intraocular lens or an Alcon monofocal intraocular lens in adults undergoing cataract surgery. The type of intraocular lens will be selected by each participant and the treating ophthalmologist as part of routine clinical care, and will not be assigned by the investigators.
Eligible participants must have a valid motor vehicle driving license and a stable history of night driving during the previous 3 months. The primary outcome will be the total score of the Visual Function and Night Driving Questionnaire (VND-Q) at 3 months postoperatively. Secondary assessments will include glare adaptation, self-rated night-driving quality and driving speed, changes in night-driving behavior, visual disturbances, distance, intermediate and near visual acuity, contrast sensitivity, whole-eye aberrations, pupil diameter, defocus performance, reading speed, spectacle independence, and participant satisfaction.
調査の概要
状態
まだ募集していません
研究の種類
観察的
入学 (推定)
200
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Lei Cai
- 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
- 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
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Adults aged 18 to 85 years with bilateral cataract who are scheduled to undergo bilateral phacoemulsification and in-the-bag implantation of either the same model of Alcon trifocal intraocular lens in both eyes or the same model of Alcon monofocal intraocular lens in both eyes.
Participants must have a valid driving license and a stable history of night driving during the 3 months before enrollment.
説明
Inclusion Criteria:
- Adults aged 18 to 85 years.
- Scheduled to undergo bilateral phacoemulsification with in-the-bag intraocular lens implantation.
- Both eyes scheduled to receive the same type and model of either an Alcon trifocal intraocular lens or an Alcon monofocal intraocular lens.
- Possession of a valid motor vehicle driving license.
- Stable night-driving behavior during the previous 3 months, with night driving occurring at least twice per month.
- Lens Opacities Classification System III nuclear opalescence grade of 4 or lower in both eyes.
- Expected intraocular lens power between +10.0 D and +36.0 D, inclusive, in both eyes.
- Ability to understand the purpose and procedures of the study and independently complete the VND-Q and visual quality questionnaires.
- Willingness to provide written informed consent and complete the scheduled postoperative follow-up visits.
Exclusion Criteria:
- Corneal endothelial cell density below 1,500 cells/mm² in either eye.
- History of ocular trauma affecting visual function, previous intraocular surgery, or previous corneal refractive surgery in either eye.
- Strabismus, amblyopia, or nystagmus in either eye.
- Any ocular disease that may affect postoperative visual acuity, contrast sensitivity, mesopic visual function, or questionnaire assessment, including but not limited to irregular corneal astigmatism, corneal scar, corneal degeneration, keratoconus, keratitis, corneal dystrophy, uveitis, severe iris atrophy, intraoperative floppy iris syndrome, microphthalmos, macrophthalmos, color vision deficiency, active ocular inflammation, advanced glaucoma or uncontrolled intraocular pressure, macular disease, retinal pigment epithelial disease, diabetic retinopathy, retinal detachment, choroidal detachment, or optic atrophy.
- A high risk of zonular rupture or an contraindication to in-the-bag intraocular lens implantation, including zonular weakness, zonular dialysis, lens subluxation or dislocation, pseudoexfoliation syndrome, Marfan syndrome, posterior capsule rupture, or cyclodialysis.
Severe or unstable systemic disease, including systemic lupus erythematosus or Sjögren syndrome.
- Use of medication judged by the investigator to increase surgical risk or affect visual function, including amiodarone, chlorpromazine, ethambutol, digitalis, or chloroquine.
- Requirement for a combined ocular procedure, including limbal relaxing incisions, intraocular drug injection, retinal laser treatment, or another combined procedure judged inappropriate by the investigator.
- Severe anxiety, depression, or another significant psychiatric disorder.
- Any other condition judged by the investigator to make participation inappropriate.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Trifocal IOL Group
Undergo bilateral phacoemulsification and implantation of Alcon trifocal intraocular lens in both eyes
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AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
|
|
Monofocal IOL Group
Undergo bilateral phacoemulsification and implantation of Alcon monofocal intraocular lens in both eyes
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Alcon Monofocal Intraocular Lens
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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 |
|---|---|---|
|
VND-Q Total Score at 3 Months After Surgery
時間枠：3 months after the second-eye surgery
|
The Visual Function and Night Driving Questionnaire (VND-Q) consists of 9 items.
Each item is rated on a 5-point Likert scale from 1, indicating no difficulty, to 5, indicating extreme difficulty.
The total score ranges from 9 to 45, with higher scores indicating greater subjective difficulty during night driving.
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3 months after the second-eye surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Glare Adaptation Item Score of the VND-Q
時間枠：3 months after the second-eye surgery
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Score of the VND-Q item assessing difficulty adapting to glare from oncoming vehicle headlights.
A higher score indicates greater difficulty with glare adaptation.
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3 months after the second-eye surgery
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Self-Rated Night-Driving Quality
時間枠：Baseline and 3 months after the second-eye surgery
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Participant-reported night-driving quality assessed using a study-specific 5-point rating scale.
Higher or lower scores will be interpreted according to the predefined questionnaire scoring system.
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Baseline and 3 months after the second-eye surgery
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Self-Rated Night-Driving Speed
時間枠：Baseline and 3 months after the second-eye surgery
|
Participant-reported assessment of usual night-driving speed using a study-specific 5-point rating scale.
|
Baseline and 3 months after the second-eye surgery
|
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Percentage of Participants Who Reduce Night Driving
時間枠：3 months after the second-eye surgery
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The number and percentage of participants reporting that they reduced their night-driving frequency after surgery, based on a binary yes-or-no questionnaire item.
|
3 months after the second-eye surgery
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Distance, Intermediate, and Near Visual Acuity
時間枠：Baseline and 3 months after the second-eye surgery
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Uncorrected distance visual acuity, uncorrected intermediate visual acuity, uncorrected near visual acuity, corrected distance visual acuity, distance-corrected intermediate visual acuity, and distance-corrected near visual acuity will be measured using logarithm of the minimum angle of resolution units.
Testing distances will be 4 m for distance, 60 cm for intermediate, and 40 cm for near vision.
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Baseline and 3 months after the second-eye surgery
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Whole-Eye Aberrations
時間枠：Baseline and 3 months after the second-eye surgery
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Whole-eye optical aberrations measured using the same wavefront aberrometry device and standardized testing parameters for all participants.
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Baseline and 3 months after the second-eye surgery
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Visual Disturbance Questionnaire Score
時間枠：Baseline and 3 months after the second-eye surgery
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Participant-reported frequency or severity of glare, halos, starbursts, and other visual disturbances assessed using a standardized visual quality questionnaire.
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Baseline and 3 months after the second-eye surgery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jin Yang、Fudan University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月30日
一次修了 (推定)
2031年8月30日
研究の完了 (推定)
2031年8月31日
試験登録日
最初に提出
2026年8月5日
QC基準を満たした最初の提出物
2026年8月5日
最初の投稿 (実際)
2026年8月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月10日
QC基準を満たした最後の更新が送信されました
2026年8月5日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- TriIOL-2026
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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