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临床试验/NCT07847749
NCT07847749尚未招募不适用

Influence of Suture Material on Postoperative Eyelid Height Stability Following Anterior White-Line Advancement for Primary Aponeurotic Ptosis: A Randomized Controlled Trial

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
58
试验地点
1
主要终点
Margin Reflex Distance 1 (MRD1)

研究概览

简要总结

What is my diagnosis and what treatment is indicated in my case? Your diagnosis is "eyelid ptosis", which means drooping of the upper eyelid. This may reduce quality of life by affecting the upper visual field and interfering with daily activities such as driving and reading. It may also cause forehead muscle fatigue, neck pain, a sad or tired appearance, eyelid asymmetry, and forehead wrinkles.

The only treatment to correct eyelid ptosis is surgery. In your case, the indicated procedure consists of reinserting the tendon of the upper eyelid levator muscle into its original position on the tarsus. This is performed using sutures to attach the tendon to the tarsus. Two types of sutures may be used: absorbable sutures, which are absorbed by the body over approximately 2-3 months, and non-absorbable sutures, which remain permanently in the eyelid because the body cannot break them down.

Why is this study being conducted? The surgery you are going to undergo is part of the standard treatment for eyelid ptosis. Both types of suture material used in this procedure are routinely used in clinical practice, meaning that either could be used even if you did not participate in the study.

Some previous studies suggest that non-absorbable sutures may maintain eyelid elevation better in the long term and reduce the need for further surgery compared with absorbable sutures. However, there is currently insufficient evidence to establish this with certainty. Most previous studies have evaluated patients who had already been treated rather than prospectively comparing both types of sutures through a randomized clinical trial, which may introduce bias when interpreting the results.

Therefore, there is currently insufficient scientific evidence to determine with certainty which suture material provides better results, and both materials continue to be routinely used in clinical practice.

The aim of this study is to compare both types of suture under controlled conditions through a randomized controlled trial, in order to determine their outcomes in the medium and long term.

How will the type of suture I receive be determined? If you agree to participate, the type of suture used during surgery will be assigned randomly by a computerized randomization system. Neither you or the surgeon will be able to choose the type of suture.

Both suture materials are routinely used in clinical practice and are authorized for this type of surgery. The only difference between the two study groups will be the material used to attach the upper eyelid levator tendon to the tarsus.

You will not be informed which type of suture was used during your surgery, although this information may be accessed if medically necessary.

What does the procedure involve? The surgery will be performed in an operating room by ophthalmologists specialized in eyelid surgery. It will be performed under local anesthesia with light sedation. This is an outpatient procedure and does not require hospital admission. The procedure lasts approximately 45-60 minutes. If removal of excess skin is required in your case, this will be performed during the same procedure.

Anterior white-line (levator tendon) advancement through the skin produces a scar within the eyelid crease. This is generally a cosmetic and well-tolerated scar.

Five visits will be required for appropriate follow-up, which is the same number of visits that would be required if you did not participate in the study: the initial visit, the day of surgery, and three follow-up visits at **2 weeks, 3 months, and 7 months**. Participation in this study does not involve any additional risk from supplementary tests.

During the study, photographs of the periocular area and face will be taken to evaluate the surgical outcomes. These images will be treated as personal health data.

If you decide to participate, you will be asked to sign an Informed Consent Form. Your participation will involve allowing information from your medical record to be collected, consenting to relevant clinical photographs, and attending the scheduled follow-up visits.

The study will be conducted at Hospital Rey Juan Carlos and aims to include 58 patients with the same condition as yours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients (cases) must meet ALL of the following criteria to be included in the study:
  • •Age >18 years.
  • •Diagnosis of primary aponeurotic eyelid ptosis.
  • •Upper eyelid levator muscle function of ≥12 mm.
  • •Acceptance and signing of informed consent to participate in the study after having received adequate information.

排除标准

  • •Patients meeting ANY of the following criteria will not be eligible to participate in the study:
  • •Diagnosis of eyelid ptosis of non-aponeurotic etiology.
  • •Diagnosis of recurrent eyelid ptosis or previous surgical treatment for ptosis.
  • •Known allergy or previous adverse reaction to any of the suture materials under investigation.
  • •Medical or surgical history that, in the investigator's judgment, precludes participation in the study.
  • •Participant with reproductive potential who is not using highly effective contraception.

研究组 & 干预措施

Group B: NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE

Experimental

干预措施: Anterior white-line advancement using a NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE. (Procedure)

Group A: ABSORBABLE suture (POLYSORB 5-0). RED CODE

Active Comparator

干预措施: Anterior white-line advancement using an ABSORBABLE suture (POLYSORB 5-0). RED CODE. (Procedure)

结局指标

主要结局

Margin Reflex Distance 1 (MRD1)

时间窗: 7 months postoperatively

次要结局

  • Margin Reflex Distance 1 (MRD1)(Basaline)
  • Margin Reflex Distance 1 (MRD1)(2 weeks postoperatively)
  • Margin Reflex Distance 1 (MRD1)(3 months postoperatively)
  • Eyelid symmetry(Basaline)
  • Eyelid symmetry(2 weeks postoperatively)
  • Eyelid symmetry(3 months postoperatively)
  • Eyelid symmetry(7 months postoperatively)
  • Ocular dominance(Basaline)
  • Hering's law dependence(Basaline)
  • Objective eyelid contour(2 weeks postoperatively)
  • Objective eyelid contour(3 moths postoperatively)
  • Objective eyelid contour(7 months postoperatively)
  • Subjective eyelid contour(2 weeks postoperatively)
  • Subjective eyelid contour(3 months postoperatively)
  • Subjective eyelid contour(7 months postoperatively)
  • Upper eyelid crease(2 weeks postoperatively)
  • Upper eyelid crease(3 months postoperatively)
  • Upper eyelid crease(7 months postoperatively)
  • Clavien-Dindo Score(Intervention day)
  • Clavien-Dindo Score(2 weeks postoperatively)
  • Clavien-Dindo Score(3 months postoperatively)
  • Clavien-Dindo Score(7 months postoperatively)
  • Reintervention(3 months postoperatively)
  • Surgical success(7 months postoperatively)
  • FACE-Q Upper Eyelid Assessment(3 months postoperatively)
  • FACE-Q Upper Eyelid Assessment(7 months postoperatively)

研究者

发起方
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Viviana Patricia Lezcano Carduz

Medical Doctor. Ophthalmologist.

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

研究点 (1)

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