An interventional study of TT Clamp and Standard BLTR Technique in Trachoma, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma which includes surgery to repair lids distorted by trachoma (trichiasis) in imminent danger of vision loss. Current evidence suggests that long-term success rates of trichiasis surgery are less than optimal due to variation in surgical technique. Previous research by this study team has demonstrated that shorter incisions have a higher rate of trichiasis recurrence. In addition, observations by this team's oculoplastic surgeon have led to the hypothesis that granuloma formation and lid contour abnormalities may result from current surgical practices. The objective of this study is to compare outcomes of trichiasis surgeries performed with the newly developed trachomatous trichiasis (TT) clamp versus surgeries following standard technique (bilamellar tarsal rotation procedure or BLTR).
Field observations in 2005 by this study's PI and oculoplastic surgeon revealed some significant departures from current trichiasis surgery procedure (bilamellar tarsal rotation procedure or BTRP), as described in the WHO manual, "Trichiasis Surgery for Trachoma-the Bilamellar Tarsal Rotation Procedure". These procedural departures were felt to contribute to adverse outcomes, including trichiasis recurrence, granuloma formation and lid contour abnormalities. This study team developed a new surgical tool, the TT clamp, to help improve surgical outcomes following BLTR.
A randomized, single-masked clinical trial will be implemented in the Mtwara region in Tanzania. Study participants will be randomized on a 1:1 basis to surgery with the TT clamp or to surgery with standard BLTR equipment. All surgeries will take place at surgical centers in Mtwara and Lindi over an 8-month period.
Baseline assessment for severity of trichiasis and other predictors of surgical failure will be carried out prior to surgery. Follow-up is planned at 2 weeks (for suture removal), 6 weeks, 12 months, and 24 months post-surgery. At each follow-up visit participants will be assessed for evidence of unfavorable outcomes, including trichiasis recurrence, granuloma formation, and lid contour abnormalities. All outcomes will be assessed clinically by a trained observer who is masked to intervention status.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 1,927 is above the median of 1,300 across 31 interventional studies indexed under Trachoma.
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Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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No previous report of trichiasis surgery in at least one eye with trichiasis:
Exclusion Criteria:
The TT clamp will be used in trichiasis surgery.
Device: TT Clamp
Standard BLTR technique will be used in trichiasis surgery.
Procedure: Standard BLTR Technique
trichiasis surgery performed with TT clamp
bilamellar tarsal rotation procedure in trichiasis surgery
Number of Eyelids With Presence of Recurrent Trichiasis
Trichiasis: 1 or more eyelashes touching globe in primary position
Time frame: 2 years
Number of Eyelids With Pyogenic Granuloma
A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.
Time frame: 2 years
Number of Eyelids Experiencing an Unfavorable Outcome
At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality
Time frame: 2 years
Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities
Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. In the primary outcome measure, normal eyes and mild eyelid contour abnormalities are considered together, and moderate or severe eyelid contour abnormalities are considered together. ECA severity is defined as follows: 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; 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; 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
Time frame: 2 years
Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality
Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. ECA severity is defined as follows: 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; 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; 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
Time frame: 2 years
Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis
Trichiasis is generally defined as 1 or more eyelashes touching globe in primary position. Classifications of trichiasis severity are as follows: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10 Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated, regardless of eyelashes touching globe
Time frame: 2 Years
Community-level eye screenings were conducted to identify all trichiasis cases in the community. Patients were scheduled for surgery. On the day of surgery they were invited to join the study if they were eligible.
| Milestone | Standard Instrumentation | TT Clamp |
|---|---|---|
| Started | 1674 | 1671 |
| Completed | 1674 | 1669 |
| Not completed | 0 | 2 |
| Withdrew: Death | 0 | 2 |
Trichiasis: 1 or more eyelashes touching globe in primary position
| eyelids | TT Clamp | Standard BLTR Technique |
|---|---|---|
| Normal | 948 | 1062 |
| TT Recurrence | 721 | 612 |
A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.
| eyelids | TT Clamp | Standard BLTR Technique |
|---|---|---|
| Granuloma | 281 | 375 |
| Normal | 1388 | 1299 |
At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality
| eyelids | TT Clamp | Standard BLTR Technique |
|---|---|---|
| Any unfavorable outcome | 1017 | 1055 |
| Normal | 652 | 619 |
Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. In the primary outcome measure, normal eyes and mild eyelid contour abnormalities are considered together, and moderate or severe eyelid contour abnormalities are considered together. ECA severity is defined as follows: 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; 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; 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
| eyelids | TT Clamp | Standard BLTR Technique |
|---|---|---|
| No/Mild ECA | 1549 | 1500 |
| Moderate/Severe ECA | 120 | 174 |
Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. ECA severity is defined as follows: 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; 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; 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
| eyelids | TT Clamp | Standard BLTR Technique |
|---|---|---|
| Normal | 1397 | 1278 |
| Mild ECA | 152 | 222 |
| Moderate ECA | 89 | 131 |
| Severe ECA | 31 | 43 |
Trichiasis is generally defined as 1 or more eyelashes touching globe in primary position. Classifications of trichiasis severity are as follows: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10 Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated, regardless of eyelashes touching globe
| eyelids | TT Clamp | Standard BLTR Technique |
|---|---|---|
| Normal | 948 | 1062 |
| Mild TT Recurrence | 476 | 417 |
| Moderate TT Recurrence | 121 | 86 |
| Severe TT Recurrence | 120 | 100 |
Collected over through 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Instrumentation | — | 0/960 (0%) | 15/960 (1.6%) |
| TT Clamp | — | 0/957 (0%) | 12/957 (1.3%) |
| Event | Standard Instrumentation | TT Clamp |
|---|---|---|
| necrosisEye disorders | 4/960 | 8/957 |
| postoperative bleedingEye disorders | 5/960 | 4/957 |
| Excess intraoperative bleedingEye disorders | 4/960 | 0/957 |
| Division of Eyelid MarginEye disorders | 2/960 | 0/957 |
1927 participants were originally enrolled. 10 participants did not undergo surgery for the following reasons: refused surgery (5), ineligible because of lower eyelid trichiasis only (4), or surgery was delayed and patient did not attend (1). The final total number of participants was 1917.
| Age, Continuous(years) | Standard Instrumentation | TT Clamp | Total |
|---|---|---|---|
| Mean | 55.6 ± 13.1 | 54.9 ± 13.5 | 55.2 ± 13.3 |
| Sex/Gender, Customized(participants) | Standard Instrumentation | TT Clamp | Total |
|---|---|---|---|
| Female | 722 | 705 | 1427 |
| Male | 238 | 252 | 490 |
| Region of Enrollment(participants) | Standard Instrumentation | TT Clamp | Total |
|---|---|---|---|
| Tanzania | 960 | 957 | 1917 |
| Trichiasis(eyelids) | Standard Instrumentation | TT Clamp | Total |
|---|---|---|---|
| mild | 347 | 303 | 650 |
| moderate | 453 | 423 | 876 |
| severe | 874 | 945 | 1819 |
Plan to share: Yes — Deidentified data will be provided to investigators through application to the data committee at Johns Hopkins University.
The record gives a start of May 2009, a primary completion of Jan 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
Results were first posted in May 2017, 5 years 4 months after primary completion.
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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