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NCT Number: NCT06935227

Steri-Strip Tape Use in Unilateral Ectropion Surgery

Currently, the incidence of involutional and chronic eyelid disorders, such as ectropion, has been increasing, as human life expectancy has risen worldwide (more than 600 million people are aged ≥ 60 years). Ectropion is a common eyelid malposition that causes visual morbidity. It is characterized by eversion of the eyelid margin and has multiple etiologies.

Steri-Strip tapes have been used in some ophthalmologic procedures, such as blepharoplasties, where they help prevent infections by acting as a barrier method, are resistant enough to reduce the risk of wound dehiscence, simplify postoperative care, and allow for proper eyelid fissure closure. Their use has been recommended in patients with facial paralysis to prevent keratitis or exposure ulcers. However, current evidence is limited, as their use has only been documented in case series and letters to the editor. Therefore, a randomized controlled clinical trial is proposed to evaluate the postoperative outcomes of Steri-Strip tape use in unilateral ectropion surgery compared to standard postoperative management.

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Key information

Conditions

Ectropion Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oftalmosanitas

Bogotá, Colombia

Location status: Recruiting

Location contact

Tatiana Gomez, MD

CONTACT

About this study

This study will compare the use of Steri-Strip tape in unilateral ectropion surgery with standard postoperative care to assess cosmetic and functional outcomes in the adult population. Participants will be followed up at 8 and 30 days after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older who are scheduled to undergo unilateral ectropion surgery.

Exclusion criteria

  • Underlying conditions associated with skin hyperlaxity, such as cutis laxa and Ehlers-Danlos syndrome.
  • Skin diseases that predispose to cicatricial ectropion, such as ichthyosis, scleroderma, and psoriasis.
  • Paralytic ectropion.
  • Current use of oral isotretinoin.

Treatment and study plan

Use Steri-Strip in post-surgery + standard care

Other

Steri-strip will be maintained for 8 days postoperatively.

Standard care

Other

Postoperative care recommendations.

Primary outcomes

  1. Eyelid position

    Time frame: Measurements will be taken in the immediate postoperative period (within the first hour) and at 30 days following surgery.

    This outcome will be assessed using the margin reflex distance 2 (MRD2), which will be measured in millimeters (mm) from the central corneal light reflex (Hirschberg reflex) to the center of the lower eyelid margin. If this measurement exceeds 5 mm, it suggests that the tapes did not provide adequate support.

Secondary outcomes

  1. Surgical wound closure

    Time frame: This will be assessed on postoperative day 8

    This outcome will be evaluated using a slit lamp and defined as complete approximation of the wound edges. It will be recorded as a binary variable: Yes/No.

  2. Visual axis obstruction secondary to peripalpebral edema

    Time frame: It will be assessed on postoperative day 8.

    This outcome will be evaluated using direct flashlight illumination. If a corneal light reflex is observed, it will indicate a clear visual axis.

  3. Ocular surface symptoms

    Time frame: This outcome will be assessed on postoperative days 8 and 30.

    These symptoms are defined as the presence of ocular dryness, foreign body sensation, burning, or tearing. Each symptom will be recorded as present or absent. The presence of one or more of these symptoms will be interpreted as the occurrence of ocular surface symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Johana Benavides, MSc

CONTACT

[email protected]

57 6015895377

Johana Benavides, MSc

CONTACT

Sponsors and collaborators

Lead sponsor

Claudia Aristizábal

Other

Registry information

Official study title

Postoperative Outcomes of Steri-Strip Surgical Tape Use in Unilateral Ectropion Surgery: A Parallel-Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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