A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery. (PREVENTECT)
A Comparative Clinical Trial Evaluating Preventive Techniques for Postoperative Ectropion Following the Subciliary Approach in Orbital Trauma.
The goal of this clinical trial is to investigate whether preventive surgical techniques can reduce the incidence of lower eyelid ectropion after the subciliary approach in adult patients undergoing surgery for orbital fractures.
The main questions it aims to answer are:
Do lateral canthopexy or orbicularis oculi suspension reduce the incidence of postoperative ectropion? Which preventive technique provides better postoperative lower eyelid outcomes?
Researchers will compare three groups: subciliary approach alone, subciliary approach with lateral canthopexy, and subciliary approach with orbicularis oculi suspension to investigate which approach is most effective in preventing postoperative ectropion.
Participants will undergo surgical treatment according to their assigned group and will attend scheduled postoperative follow-up visits for clinical evaluation of lower eyelid position and surgical outcomes.
調査の概要
状態
詳細な説明
Orbital fractures commonly require surgical reconstruction to restore orbital anatomy and function. The subciliary approach provides excellent surgical exposure but may be associated with postoperative lower eyelid malposition, particularly ectropion, which can affect both function and appearance. Several preventive surgical techniques, including lateral canthopexy and orbicularis oculi muscle suspension, have been proposed to reduce this complication; however, evidence comparing their effectiveness remains limited.
This prospective randomized controlled clinical trial will compare three treatment groups: subciliary approach, subciliary approach with lateral canthopexy, and subciliary approach with orbicularis oculi suspension. Participants will be followed postoperatively to evaluate the incidence of ectropion and other lower eyelid outcomes. The findings will provide evidence regarding the effects of these techniques on postoperative lower eyelid position and ectropion following orbital fracture repair.
The orbital fracture repair will be performed through a standardized subciliary approach in all study groups. According to randomization, participants will receive either lateral canthopexy, orbicularis oculi suspension, or no additional lower eyelid procedure. The specific surgical techniques, including suture placement, tissue fixation, suture material, tension, and periosteal fixation, will be standardized across participants within each intervention group. All surgical procedures will be performed by the same surgeon across all three study groups to ensure consistency of the surgical technique and minimize operator-related variability.
Postoperative Management: All participants in the three study groups will receive standardized postoperative management, including Frost suture, eyelid taping, eyelid massage, corticosteroid therapy, and postoperative dressing. The same postoperative management protocol will be applied to all treatment groups to ensure consistency of postoperative care.
Before randomization and surgery, all participants will undergo a standardized preoperative assessment of the lower eyelid and lateral canthal position. The assessment will include measurement of baseline margin reflex distance 2 (MRD2), evaluation of scleral show, lower eyelid position, canthal tilt, and lateral canthal position. Standardized clinical assessment of lower eyelid laxity will also be performed using the snap-back test and eyelid distraction test. Standardized preoperative photographs will be obtained using consistent patient positioning and standardized views to document baseline eyelid and lateral canthal anatomy.
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：Yasmin Abdelfattah, BDS
- 電話番号：+20 1116104101
- メール：yasmin.a7med16@yahoo.com
研究連絡先のバックアップ
- 名前：Mohamed S. Elkhouly, PhD
- 電話番号：+20 1002318399
- メール：mohammed.s.elkhouly@minia.edu.eg
参加基準
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
説明
Inclusion Criteria:
- Systemically healthy patients aged 18 years or older, with no history of chronic or uncontrolled systemic diseases.
- Patients with primary orbital trauma requiring surgical treatment through a standardized subciliary approach, presenting with orbital floor fractures with or without associated lateral orbital rim fractures involving the lateral canthal tendon region, and without associated zygomaticomaxillary complex (ZMC) fractures.
Exclusion Criteria:
- Secondary orbital trauma (revision cases or patients with previous orbital trauma).
- Previous lower eyelid surgery.
- Pre-existing eyelid malposition (ectropion or entropion) or other pre-existing lower eyelid or lateral canthal abnormalities.
- Uncontrolled systemic conditions that may affect wound healing, eyelid integrity, or lower eyelid laxity, including uncontrolled diabetes mellitus, immunocompromised status, chronic corticosteroid therapy, or collagen vascular diseases.
- Previous radiotherapy to the orbital or facial region.
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：防止
- 割り当て：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 |
|---|---|
|
アクティブコンパレータ：Subciliary Approach
Participants will undergo orbital fracture repair using the subciliary approach.
|
Standardized subciliary approach for orbital fracture repair.
The skin incision will be placed approximately 2 mm below the lower eyelid margin within a natural skin crease, extending from approximately 1 mm temporal to the inferior punctum toward the lateral canthal region.
A stepped skin-muscle approach will be used, with the skin incision followed by inferior subcutaneous dissection and subsequent incision of the preseptal orbicularis oculi muscle approximately 7 mm inferior to the subciliary margin.
Dissection will proceed to the infraorbital rim while maintaining the integrity of the orbital septum.
The periosteum will be incised approximately 3-4 mm below the inferior orbital rim on its facial aspect to obtain surgical exposure.
|
|
実験的：Subciliary Approach with Lateral Canthopexy
Participants will undergo orbital fracture repair using the subciliary approach combined with lateral canthopexy.
The effect of lateral canthopexy on postoperative lower eyelid position and the incidence of ectropion will be evaluated.
|
Standardized subciliary approach for orbital fracture repair.
The skin incision will be placed approximately 2 mm below the lower eyelid margin within a natural skin crease, extending from approximately 1 mm temporal to the inferior punctum toward the lateral canthal region.
A stepped skin-muscle approach will be used, with the skin incision followed by inferior subcutaneous dissection and subsequent incision of the preseptal orbicularis oculi muscle approximately 7 mm inferior to the subciliary margin.
Dissection will proceed to the infraorbital rim while maintaining the integrity of the orbital septum.
The periosteum will be incised approximately 3-4 mm below the inferior orbital rim on its facial aspect to obtain surgical exposure.
Lateral Canthopexy Technique: A 4-0 polydioxanone (PDS) suture on a P2 needle will be placed through the periosteum of the inner aspect of the lateral orbital rim over Whitnall's tubercle at the desired height.
The suture will then engage the medial end of the lateral canthal tendon and the lateral border of the lower eyelid tarsus in a vertical direction.
The suture will be tied with the lower eyelid positioned at the desired height.
Periosteal fixation will be used.
|
|
実験的：Subciliary Approach with Orbicularis Oculi Suspension
Participants will undergo orbital fracture repair using the subciliary approach combined with orbicularis oculi suspension.
The effect of orbicularis oculi suspension on postoperative lower eyelid position and the incidence of ectropion will be evaluated.
|
Standardized subciliary approach for orbital fracture repair.
The skin incision will be placed approximately 2 mm below the lower eyelid margin within a natural skin crease, extending from approximately 1 mm temporal to the inferior punctum toward the lateral canthal region.
A stepped skin-muscle approach will be used, with the skin incision followed by inferior subcutaneous dissection and subsequent incision of the preseptal orbicularis oculi muscle approximately 7 mm inferior to the subciliary margin.
Dissection will proceed to the infraorbital rim while maintaining the integrity of the orbital septum.
The periosteum will be incised approximately 3-4 mm below the inferior orbital rim on its facial aspect to obtain surgical exposure.
A standardized orbicularis oculi suspension procedure performed in conjunction with the subciliary approach.
Following the subciliary incision, the orbicularis oculi muscle is split 7 mm inferior to the subciliary margin while preserving pretarsal muscle function.
The lateral edge of the preseptal orbicularis oculi muscle is bluntly dissected to the lateral orbital rim and suspended to the periosteum at the anchoring point using a Vicryl 5-0 or 6-0 horizontal mattress suture with appropriate tension.
|
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 |
|---|---|---|
|
Incidence of postoperative lower eyelid ectropion
時間枠：1 week, 1 month, 3 months, and 6 months postoperatively
|
The proportion of participants who develop postoperative lower eyelid ectropion after orbital fracture repair.
Ectropion will be assessed clinically by an examiner blinded to treatment allocation using the Ectropion Grading Scale (EGS), a standardized grading system for assessing the severity of lower eyelid ectropion.
The severity will be graded from Grade 0 (normal eyelid position) to Grade V (severe ectropion with associated complications).
Standardized postoperative photographs will also be obtained using consistent patient positioning and standardized views at each assessment time point to facilitate comparison of postoperative lower eyelid position and ectropion severity over time.
|
1 week, 1 month, 3 months, and 6 months postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in lower margin reflex distance 2 (MRD2) from baseline
時間枠：1 week, 1 month, 3 months, and 6 months postoperatively
|
Change in lower margin reflex distance 2 (MRD2) from baseline will be measured clinically by an examiner blinded to treatment allocation.
MRD2 will be defined as the distance, in millimeters, between the central corneal light reflex and the lower eyelid margin, measured with the patient in primary gaze using a standardized measurement technique.
Standardized frontal photographs will also be obtained at each assessment time point using consistent patient positioning to facilitate documentation and evaluation of postoperative lower eyelid position.
|
1 week, 1 month, 3 months, and 6 months postoperatively
|
|
Inferior scleral show
時間枠：1 week, 1 month, 3 months, and 6 months postoperatively
|
The amount of inferior scleral show will be assessed clinically by an examiner blinded to treatment allocation and measured in millimeters as the visible scleral area between the lower eyelid margin and the inferior limbus in primary gaze.
Standardized frontal photographs will also be obtained at each assessment time point to facilitate comparison of lower eyelid position over time.
|
1 week, 1 month, 3 months, and 6 months postoperatively
|
|
Postoperative lower eyelid retraction
時間枠：1 week, 1 month, 3 months, and 6 months postoperatively
|
The presence and severity of postoperative lower eyelid retraction will be assessed clinically by an examiner blinded to treatment allocation, based on inferior displacement of the lower eyelid margin relative to its baseline position.
Assessment will be supported by standardized clinical measurements and photographs.
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1 week, 1 month, 3 months, and 6 months postoperatively
|
|
Ectropion severity
時間枠：1 week, 1 month, 3 months, and 6 months postoperatively
|
The severity of postoperative lower eyelid ectropion will be assessed clinically by an examiner blinded to treatment allocation using the Ectropion Grading Scale (EGS), a standardized grading system ranging from Grade 0 (normal eyelid position) to Grade V (severe ectropion with associated complications).
Standardized postoperative photographs will also be obtained to facilitate assessment of ectropion severity over time.
|
1 week, 1 month, 3 months, and 6 months postoperatively
|
|
Subciliary scar assessment
時間枠：1 month, 3 months, and 6 months postoperatively
|
The subciliary surgical scar will be assessed clinically for visibility, quality, and the presence of hypertrophic scarring by an examiner blinded to treatment allocation.
Standardized photographs will also be obtained to facilitate assessment of scar appearance.
|
1 month, 3 months, and 6 months postoperatively
|
|
Patient satisfaction
時間枠：1 month, 3 months, and 6 months postoperatively
|
Patient-reported functional and aesthetic satisfaction following surgery will be assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10. Patients will rate their functional satisfaction and aesthetic satisfaction separately, with 0 indicating complete dissatisfaction and 10 indicating complete satisfaction.
The same assessment will be performed at each postoperative time point to allow comparison of patient-reported satisfaction over time and among the three treatment groups.
|
1 month, 3 months, and 6 months postoperatively
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Hamed Gad, PhD、Faculty of Dentistry, Minia University
- スタディディレクター：Alaa Othman, PhD、Samalout Specialized Hospital
- スタディディレクター：Mohamed S. Elkhouly, PhD、Faculty of Dentistry, Minia University
出版物と役立つリンク
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
本研究に関する用語
キーワード
その他の研究ID番号
- OMFS-ECT-2026-01
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