Influence of Implantation Technique on Rotational Stability of a Frosted-Haptic Toric Intraocular Lens: A Prospective Contralateral-Eye Study
This prospective, randomized contralateral-eye study evaluates whether the implantation technique influences the rotational stability and refractive outcomes of the TECNIS Eyhance™ Toric II intraocular lens (IOL) during cataract surgery. Although balanced salt solution (BSS) hydroimplantation has been proposed to reduce postoperative IOL rotation by eliminating retained ophthalmic viscosurgical device (OVD), the effect of implantation technique on the rotational stability of modern frosted-haptic toric IOLs remains uncertain.
Patients undergoing bilateral cataract surgery with regular corneal astigmatism receive TECNIS Eyhance™ Toric II IOLs in both eyes. One eye is randomized to OVD-assisted implantation and the fellow eye to BSS-assisted hydroimplantation. The primary outcome is postoperative rotational stability assessed using OPD-Scan III at postoperative day 1, week 1, and month 1. Secondary outcomes include postoperative refractive astigmatism, astigmatic prediction error, and visual acuity. The study aims to determine whether implantation technique influences postoperative rotational stability or refractive performance when using a contemporary frosted-haptic toric IOL.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Dr.
-
Cairo、Dr.、エジプト、11765
- AinShams university
-
-
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:
- Adults with senile cataract requiring bilateral cataract surgery.
- Regular corneal astigmatism of ≥1.00 diopter.
- Axial length between 22.0 mm and 25.0 mm.
- Eligible for implantation with the TECNIS Eyhance™ Toric II intraocular lens.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Inconsistent corneal astigmatism measurements (difference >0.20 D in magnitude or >5° in axis among the four diagnostic devices).
- Visually significant dry eye disease with positive corneal fluorescein staining.
Irregular corneal astigmatism or corneal opacity.
- Ocular comorbidities that could affect toric IOL stability or visual outcomes (e.g., pseudoexfoliation syndrome, advanced glaucoma, or macular pathology).
- Intraoperative complications or generalized zonular weakness requiring implantation of a capsular tension ring.
- Significant postoperative day 1 corneal edema precluding reliable rotational measurements.
- Inability to comply with 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：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：OVD-assisted Implantation
Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device (ProVisc) during cataract surgery.
|
Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device.
|
|
実験的：BSS-assisted hydroimplantation
Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution hydroimplantation during cataract surgery.
|
Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution instead of an ophthalmic viscosurgical device.
|
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 |
|---|---|---|
|
Absolute rotational stability of the TECNIS Eyhance Toric II intraocular lens
時間枠：Postoperative day 1, week 1, and month 1
|
Absolute intraocular lens rotation (degrees) measured relative to the final intraoperative implantation axis using the OPD-Scan III.
Rotation was calculated as the absolute angular difference between the intraoperative reference axis and the postoperative axis
|
Postoperative day 1, week 1, and month 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Residual refractive astigmatism
時間枠：3 months after surgery
|
Postoperative refractive astigmatism measured at the corneal plane by manifest refraction.
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3 months after surgery
|
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Astigmatic prediction error
時間枠：3 months after surgery
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Absolute prediction error calculated as the absolute difference between the predicted and postoperative refractive astigmatism.
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3 months after surgery
|
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Uncorrected Distance Visual Acuity (UDVA)
時間枠：3 months after surgery
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Monocular uncorrected distance visual acuity measured using a standardized visual acuity chart.
|
3 months after surgery
|
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Corrected Distance Visual Acuity (CDVA)
時間枠：3 months after surgery
|
3 months after surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ahmed Assaf, MD, PhD、AinShams university
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
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
キーワード
その他の研究ID番号
- 200/2026
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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