EctropionNCT06935227
Steri-Strip Tape Use in Unilateral Ectropion Surgery
A study of Ectropion, run by Claudia Aristizábal at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ectropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteColombia
- Study dates
- 1 May 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older who are scheduled to undergo unilateral ectropion surgery.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johana Benavides, MSc contact
Colombia1 site, 1 recruiting
- Recruiting
Oftalmosanitas
Bogotá
Tatiana Gomez, MD
About this study
Official title: Postoperative Outcomes of Steri-Strip Surgical Tape Use in Unilateral Ectropion Surgery: A Parallel-Controlled Clinical 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.
Read the 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.
- Conditions
- Ectropion
- Being tested
- Use Steri-Strip in post-surgery + standard care, Standard care
- Medical subject headings
- Ectropion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use Steri-Strip in post-surgery + standard careOther
Steri-strip will be maintained for 8 days postoperatively.
Standard careOther
Postoperative care recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Use Steri-Strip in post-surgery + standard care | Active comparator | Within the first hour after unilateral ectropion surgery, Steri-Strip tapes (6 mm wide × 100 mm long, pack of 10 strips) will be applied to the operated eye. Six of these strips will be placed obliquely, hammock-style, 3 mm below the inferior orbital rim to direct the tension forces upward, using the lateral canthus of the operated eye as support. An additional strip will be placed horizontally, 2 mm above the orbital rim. The Steri-Strip tapes will be removed 8 days after surgery. Receives: Other: Use Steri-Strip in post-surgery + standard care |
| Standard care | Other | Standard care for ectropion surgery refers to the usual postoperative management provided without the use of additional supportive devices such as Steri-Strip tapes. It typically includes the application of ophthalmic antibiotic ointment, cold compresses, and instructions for eyelid hygiene. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements will be taken in the immediate postoperative period (within the first hour) and at 30 days following surgery.
Secondary outcomes (3)
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.
Measured: This will be assessed on postoperative day 8
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.
Measured: It will be assessed on postoperative day 8.
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.
Measured: This outcome will be assessed on postoperative days 8 and 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 May 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EctropionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Aristizábal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Aristizábal, Sanitas University
- Investigators
- Tatiana Gomez, MD, Principal investigator, Unisanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935227
- Sponsor's protocol ID
- Steri-Strip Post-Surgery
- Status last verified
- Jun 2025
- First submitted
- 11 Apr 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes of Steri-Strip Surgical Tape Use in Unilateral Ectropion Surgery: A Parallel-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06935227
- Acronym / sponsor ID
- Steri-Strip Post-Surgery
- Conditions
- Ectropion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Claudia AristizábalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use Steri-Strip in post-surgery + standard care | Active comparator | Other: Use Steri-Strip in post-surgery + standard careWithin the first hour after unilateral ectropion surgery, Steri-Strip tapes (6 mm wide × 100 mm long, pack of 10 strips) will be applied to the operated eye. Six of these strips will be placed obliquely, hammock-style, 3 mm below the inferior orbital rim to direct the tension forces upward, using the lateral canthus of the operated eye as support. An additional strip will be placed horizontally, 2 mm above the orbital rim. The Steri-Strip tapes will be removed 8 days after surgery. |
| Standard care | Other | Other: Standard careStandard care for ectropion surgery refers to the usual postoperative management provided without the use of additional supportive devices such as Steri-Strip tapes. It typically includes the application of ophthalmic antibiotic ointment, cold compresses, and instructions for eyelid hygiene. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years or older who are scheduled to undergo unilateral ectropion surgery.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use Steri-Strip in post-surgery + standard careSteri-strip will be maintained for 8 days postoperatively. | Other | Use Steri-Strip in post-surgery + standard care |
| Standard carePostoperative care recommendations. | Other | Standard care |
Primary outcome
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.
3 secondary outcomes
Surgical wound closure
Time frame: This will be assessed on postoperative day 8
Visual axis obstruction secondary to peripalpebral edema
Time frame: It will be assessed on postoperative day 8.
Ocular surface symptoms
Time frame: This outcome will be assessed on postoperative days 8 and 30.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johana Benavides, MSc contact
Tatiana Gomez, MD principal investigator
Unisanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Ectropion, run by Claudia Aristizábal at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johana Benavides, MSc (57 6015895377, jbenavidescr@unisanitas.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyelid position (time frame: Measurements will be taken in the immediate postoperative period (within the first hour) and at 30 days following surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.