Trial Outcomes & Findings for Modified Instrumentation for Surgery to Correct Trichiasis (NCT NCT00886015)

NCT ID: NCT00886015

Last Updated: 2017-05-19

Results Overview

Trichiasis: 1 or more eyelashes touching globe in primary position

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1927 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-05-19

Participant Flow

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.

963 individuals assigned to Trachomatous Trichiasis (TT) clamp, 6 did not participate. 3 refused surgery, 2 ineligible because of lower eyelid trichiasis only, 1 participant did not present for surgery. 964 individuals assigned to Standard, 4 did not participate. 2 refused surgery, 2 ineligible because of lower eyelid trichiasis only.

Participant milestones

Measure	Standard Instrumentation Eyelids operated with standard BLTR instrumentation	TT Clamp Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
Overall Study STARTED	1674	1671
Overall Study COMPLETED	1674	1669
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Standard Instrumentation Eyelids operated with standard BLTR instrumentation	TT Clamp Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
Overall Study Death	0	2

Baseline Characteristics

Modified Instrumentation for Surgery to Correct Trichiasis

Baseline characteristics by cohort

Measure	Standard Instrumentation n=960 Participants Eyelids operated with standard BLTR instrumentation	TT Clamp n=957 Participants Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate	Total n=1917 Participants Total of all reporting groups
Sex/Gender, Customized Female	722 participants n=5 Participants	705 participants n=7 Participants	1427 participants n=5 Participants
Sex/Gender, Customized Male	238 participants n=5 Participants	252 participants n=7 Participants	490 participants n=5 Participants
Region of Enrollment Tanzania	960 participants n=5 Participants	957 participants n=7 Participants	1917 participants n=5 Participants
Trichiasis mild	347 eyelids n=5 Participants	303 eyelids n=7 Participants	650 eyelids n=5 Participants
Trichiasis moderate	453 eyelids n=5 Participants	423 eyelids n=7 Participants	876 eyelids n=5 Participants
Trichiasis severe	874 eyelids n=5 Participants	945 eyelids n=7 Participants	1819 eyelids n=5 Participants
Age, Continuous	55.6 years STANDARD_DEVIATION 13.1 • n=5 Participants	54.9 years STANDARD_DEVIATION 13.5 • n=7 Participants	55.2 years STANDARD_DEVIATION 13.3 • n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Of the 1671 eyes initially assigned to TT Clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up.

Trichiasis: 1 or more eyelashes touching globe in primary position

Outcome measures

Measure	TT Clamp n=1669 eyelids The TT clamp will be used in trichiasis surgery. TT Clamp: trichiasis surgery performed with TT clamp	Standard BLTR Technique n=1674 eyelids Standard BLTR technique will be used in trichiasis surgery. Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery
Number of Eyelids With Presence of Recurrent Trichiasis Normal	948 eyelids	1062 eyelids
Number of Eyelids With Presence of Recurrent Trichiasis TT Recurrence	721 eyelids	612 eyelids

PRIMARY outcome

Timeframe: 2 years

Population: Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up

A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.

Outcome measures

Measure	TT Clamp n=1669 eyelids The TT clamp will be used in trichiasis surgery. TT Clamp: trichiasis surgery performed with TT clamp	Standard BLTR Technique n=1674 eyelids Standard BLTR technique will be used in trichiasis surgery. Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery
Number of Eyelids With Pyogenic Granuloma Granuloma	281 eyelids	375 eyelids
Number of Eyelids With Pyogenic Granuloma Normal	1388 eyelids	1299 eyelids

PRIMARY outcome

Timeframe: 2 years

Population: Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up

At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality

Outcome measures

Measure	TT Clamp n=1669 eyelids The TT clamp will be used in trichiasis surgery. TT Clamp: trichiasis surgery performed with TT clamp	Standard BLTR Technique n=1674 eyelids Standard BLTR technique will be used in trichiasis surgery. Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery
Number of Eyelids Experiencing an Unfavorable Outcome Any unfavorable outcome	1017 eyelids	1055 eyelids
Number of Eyelids Experiencing an Unfavorable Outcome Normal	652 eyelids	619 eyelids

PRIMARY outcome

Timeframe: 2 years

Population: Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up

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

Outcome measures

Measure	TT Clamp n=1669 eyelids The TT clamp will be used in trichiasis surgery. TT Clamp: trichiasis surgery performed with TT clamp	Standard BLTR Technique n=1674 eyelids Standard BLTR technique will be used in trichiasis surgery. Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery
Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities No/Mild ECA	1549 eyelids	1500 eyelids
Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities Moderate/Severe ECA	120 eyelids	174 eyelids

SECONDARY outcome

Timeframe: 2 years

Population: Of the 1771 participants originally assigned to TT Clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up

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

Outcome measures

Measure	TT Clamp n=1669 eyelids The TT clamp will be used in trichiasis surgery. TT Clamp: trichiasis surgery performed with TT clamp	Standard BLTR Technique n=1674 eyelids Standard BLTR technique will be used in trichiasis surgery. Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery
Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality Normal	1397 eyelids	1278 eyelids
Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality Mild ECA	152 eyelids	222 eyelids
Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality Moderate ECA	89 eyelids	131 eyelids
Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality Severe ECA	31 eyelids	43 eyelids

SECONDARY outcome

Timeframe: 2 Years

Population: Of the 1669 TT eyelids and 1674 BLTR eyelids included in the initial analysis, 13 eyes (4 in the TT clamp group, 9 in the BLTR group) without TT at 1 year underwent operation between years 1 and 2. They are not included in the data for severity of recurrence because we do not know the TT severity.

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

Outcome measures

Measure	TT Clamp n=1665 eyelids The TT clamp will be used in trichiasis surgery. TT Clamp: trichiasis surgery performed with TT clamp	Standard BLTR Technique n=1665 eyelids Standard BLTR technique will be used in trichiasis surgery. Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery
Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis Normal	948 eyelids	1062 eyelids
Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis Mild TT Recurrence	476 eyelids	417 eyelids
Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis Moderate TT Recurrence	121 eyelids	86 eyelids
Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis Severe TT Recurrence	120 eyelids	100 eyelids

Adverse Events

Standard Instrumentation

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

TT Clamp

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard Instrumentation n=960 participants at risk Eyelids operated with standard BLTR instrumentation	TT Clamp n=957 participants at risk Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
Eye disorders Excess intraoperative bleeding	0.42% 4/960 • Number of events 4 • through 2 years	0.00% 0/957 • through 2 years
Eye disorders Division of Eyelid Margin	0.21% 2/960 • Number of events 2 • through 2 years	0.00% 0/957 • through 2 years
Eye disorders postoperative bleeding	0.52% 5/960 • Number of events 5 • through 2 years	0.42% 4/957 • Number of events 4 • through 2 years
Eye disorders necrosis	0.42% 4/960 • Number of events 4 • through 2 years	0.84% 8/957 • Number of events 8 • through 2 years

Additional Information

Sheila West

JohnHopkins U

Phone: 410-955-2606

Email: shwest@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place