Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery. (PREVENTECT)

2026. augusztus 16. frissítette: Yasmin Ahmed Moustafa Kamal Abdelfattah, Minia University

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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

30

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Megelőzés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Aktív összehasonlító: Subciliary Approach
Participants will undergo orbital fracture repair using the subciliary approach.
Eljárás: 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.
Kísérleti: 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.
Eljárás: 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.
Eljárás: Lateral Canthopexy
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.
Kísérleti: 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.
Eljárás: 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.
Eljárás: Orbicularis Oculi Suspension
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Incidence of postoperative lower eyelid ectropion
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in lower margin reflex distance 2 (MRD2) from baseline
Időkeret: 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
Időkeret: 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
Időkeret: 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.
1 week, 1 month, 3 months, and 6 months postoperatively
Ectropion severity
Időkeret: 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
Időkeret: 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
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Minia University

Nyomozók

  • Kutatásvezető: Hamed Gad, PhD, Faculty of Dentistry, Minia University
  • Tanulmányi igazgató: Alaa Othman, PhD, Samalout Specialized Hospital
  • Tanulmányi igazgató: Mohamed S. Elkhouly, PhD, Faculty of Dentistry, Minia University

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. szeptember 1.

Elsődleges befejezés (Becsült)

2027. október 31.

A tanulmány befejezése (Becsült)

2027. november 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 7.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 16.

Első közzététel (Tényleges)

2026. augusztus 20.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 20.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 16.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • OMFS-ECT-2026-01

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

Individual participant data will not be shared due to confidentiality and institutional ethical requirements.

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Iratkozz fel