Ectropion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERUse Steri-Strip in post-surgery + standard care
Steri-strip will be maintained for 8 days postoperatively.
OTHERStandard care
Postoperative care recommendations.
Sponsors
Claudia Aristizábal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eyelid position | 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
| Measure | Time frame | Description |
|---|---|---|
| Surgical wound closure | 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. |
| Visual axis obstruction secondary to peripalpebral edema | 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. |
| Ocular surface symptoms | 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. |
Countries
Colombia
Contacts
Primary ContactJohana Benavides, MSc
Backup ContactJohana Benavides, MSc
Outcome results
None listed