TrichiasisPTTNCT03886519
Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
A study testing BRAP (Bevel/rotate/advance procedure) and Trabut in people with Trichiasis and Surgery, run by University of North Carolina, Chapel Hill at 1 site in Ethiopia.
Trial summary
The objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the Bevel/rotate/advance procedure (BRAP), to the Trabut procedure among repeat surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichiasis, Surgery
- What is being tested?
- BRAP (Bevel/rotate/advance procedure) and Trabut
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 886 participants
- Where
- 1 siteEthiopia
- Study dates
- 13 Apr 2019to 22 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aged 18 or older
- At least one eyelid with post-operative upper eyelid trichiasis
- Willing to comply with all study procedures and be available for the duration of the study
Who cannot join
- Inability to provide independent, informed consent
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Orbis Ethiopia
Hosa’ina, Southerns Nations, Nationalities, and Peoples' Region
About this study
The objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the Bevel/rotate/advance procedure (BRAP), to the Trabut procedure among repeat surgery patients.
Read the detailed description
The investigators will randomize participants with previously operated trichiasis on a 1:1 basis to receive either the Bevel/rotate/advance procedure (BRAP) or the Trabut procedure. The participants will be followed at 1 day, 2 weeks, 3-6 months, and then 12 months following the surgery. The primary study endpoint is recurrence of post-operative trichiasis within 12 months of surgery. The investigators will conduct logistic regression analysis comparing post-operative trichiasis recurrent rates in participants receiving BRAP versus participants receiving Trabut. Adjusted analyses will account for demographic characteristics as well as trichiasis severity prior to surgery.
- Conditions
- Trichiasis, Surgery
- Being tested
- BRAP (Bevel/rotate/advance procedure), Trabut
- Medical subject headings
- Trichiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRAP (Bevel/rotate/advance procedure)Procedure or surgery
Also called BRAP procedure
Trichiasis surgery using the BRAP procedure
TrabutProcedure or surgery
Also called Trabut procedure
Trichiasis surgery using the Trabut procedure
| Study group | Role | What they receive |
|---|---|---|
| BRAP (Bevel/rotate/advance procedure) | Active comparator | The BRAP procedure is a full-thickness beveled full-thickness incision Receives: Procedure: BRAP (Bevel/rotate/advance procedure) |
| Trabut 3 mm | Active comparator | The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line. Receives: Procedure: Trabut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eyelids With Post-operative Trichiasis Within 12 Months
Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
Measured: 10-20 months
Secondary outcomes (7)
Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months
Presence of post-operative trichiasis defined as at least one trichiatic eyelash or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze.
Measured: 3-6 months
Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months
Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated.
Trichiasis severity will be defined using the following categories:
- Mild: 1-4 eyelashes touching globe and no epilation OR <1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and <1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and <1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated
Measured: 3-6 months
Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months
Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated.
Trichiasis severity will be defined using the following categories:
- Mild: 1-4 eyelashes touching globe and no epilation OR <1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and <1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and <1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated.
Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
Measured: 10-20 months
Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System
The change in PTT severity between 3-6 months and 12 months will be measured in eyes with PTT at 3-6 months that also were examined at the 12-month visit. Change will be measured in the difference in the number of categories between 3-6 month and 1 year outcome. For example, Mild to Severe would be a 2 category change.
Measured: 10-20 months
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months
The examiner will assess for eyelid contour abnormalities (ECA) and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe.
The definitions for the categories are: 1) Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length. 2) Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length 3) Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid len
Measured: 3-6 months
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months
The examiner in the field will assess for eyelid contour abnormalities and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe.
The definitions for the categories are: 1) Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length. 2) Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length 3) Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Measured: 10-20 months
Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months
Pyogenic granulomas occasionally develop after trichiasis surgery. It is thought that this is a response to a foreign material, such as a sutures or an incision edge. All granulomas will be noted regardless of size. The investigators will count granulomas observed at the 3-6 month visit (including participants where the granuloma was removed) and granulomas observed at the 12 month visit. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
Measured: 10-20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start13 Apr 2019
- Primary completion22 Oct 2022
- Study completion22 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrichiasisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Orbis, National Eye Institute (NEI), University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- Emily Gower, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886519
- Sponsor's protocol ID
- 17-2766
- Other IDs
- UG1EY025992-04S1
- Acronym
- PTT
- Status last verified
- Aug 2022
- First submitted
- 20 Mar 2019
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made available at the time of publication of the primary and pre-planned secondary results papers.
Publications
Gower EW, West SK, Cassard SD, Munoz BE, Harding JC, Merbs SL. Definitions and standardization of a new grading scheme for eyelid contour abnormalities after trichiasis surgery. PLoS Negl Trop Dis. 2012;6(6):e1713. doi: 10.1371/journal.pntd.0001713. Epub 2012 Jun 26.
PubMed 22745845
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
- ClinicalTrials.gov ID
- NCT03886519
- Acronym / sponsor ID
- PTT / 17-2766
- Conditions
- Trichiasis, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Orbis, National Eye Institute (NEI), University of Maryland, Baltimore
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 22 Oct 2022 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the Bevel/rotate/advance procedure (BRAP), to the Trabut procedure among repeat surgery patients.
Detailed description
The investigators will randomize participants with previously operated trichiasis on a 1:1 basis to receive either the Bevel/rotate/advance procedure (BRAP) or the Trabut procedure. The participants will be followed at 1 day, 2 weeks, 3-6 months, and then 12 months following the surgery. The primary study endpoint is recurrence of post-operative trichiasis within 12 months of surgery. The investigators will conduct logistic regression analysis comparing post-operative trichiasis recurrent rates in participants receiving BRAP versus participants receiving Trabut. Adjusted analyses will account for demographic characteristics as well as trichiasis severity prior to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRAP (Bevel/rotate/advance procedure) | Active comparator | Procedure: BRAP (Bevel/rotate/advance procedure)The BRAP procedure is a full-thickness beveled full-thickness incision |
| Trabut 3 mm | Active comparator | Procedure: TrabutThe Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or older
- At least one eyelid with post-operative upper eyelid trichiasis
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (1 listed)
- Inability to provide independent, informed consent
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 |
|---|---|---|
| BRAP (Bevel/rotate/advance procedure)Also: BRAP procedureTrichiasis surgery using the BRAP procedure | Procedure or surgery | BRAP (Bevel/rotate/advance procedure) |
| TrabutAlso: Trabut procedureTrichiasis surgery using the Trabut procedure | Procedure or surgery | Trabut 3 mm |
Primary outcome
Number of Eyelids With Post-operative Trichiasis Within 12 Months
Time frame: 10-20 months
Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
7 secondary outcomes
Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months
Time frame: 3-6 months
Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months
Time frame: 3-6 months
Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months
Time frame: 10-20 months
Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System
Time frame: 10-20 months
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months
Time frame: 3-6 months
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months
Time frame: 10-20 months
Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months
Time frame: 10-20 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22745845Gower EW, West SK, Cassard SD, Munoz BE, Harding JC, Merbs SL. Definitions and standardization of a new grading scheme for eyelid contour abnormalities after trichiasis surgery. PLoS Negl Trop Dis. 2012;6(6):e1713. doi: 10.1371/journal.pntd.0001713. Epub 2012 Jun 26.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available at the time of publication of the primary and pre-planned secondary results papers.
Related trials for Trichiasis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
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. This study is not recruiting at the moment.
Emily Gower, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRAP (Bevel/rotate/advance procedure) and Trabut in people with Trichiasis and Surgery, run by University of North Carolina, Chapel Hill at 1 site in Ethiopia.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 22 Feb 2024. 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 Ethiopia. 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?
Yes. Results are posted in the registry (first posted 22 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Eyelids With Post-operative Trichiasis Within 12 Months (time frame: 10-20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03886519, which also lists 1 linked publication.
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 22 Feb 2024.