Steri-Strip Tape Use in Unilateral Ectropion Surgery
ConditionEctropion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClaudia Aristizábal
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older who are scheduled to undergo unilateral ectropion surgery.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Use Steri-Strip in post-surgery + standard care
Other interventionSteri-strip will be maintained for 8 days postoperatively.
Standard care
Other interventionPostoperative care recommendations.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Use Steri-Strip in post-surgery + standard careActive comparator 1 intervention
Group B: Standard careOther 1 intervention
Trial outcomes
Primary outcomes
1
Eyelid position
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.
Time frame
Measurements will be taken in the immediate postoperative period (within the first hour) and at 30 days following surgery.Secondary outcomes
1
Surgical wound closure
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.
Time frame
This will be assessed on postoperative day 82
Visual axis obstruction secondary to peripalpebral edema
This outcome will be evaluated using direct flashlight illumination. If a corneal light reflex is observed, it will indicate a clear visual axis.
Time frame
It will be assessed on postoperative day 8.3
Ocular surface symptoms
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.
Time frame
This outcome will be assessed on postoperative days 8 and 30.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Claudia Aristizábal
Lead sponsor
Sanitas University
Sponsor institution
Source ClinicalTrials.gov