Trial Outcomes & Findings for Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old (NCT NCT00780741)
NCT ID: NCT00780741
Last Updated: 2016-06-24
Results Overview
Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.
COMPLETED
PHASE3
220 participants
18 months of age
2016-06-24
Participant Flow
Between November 2008 and September 2010, 163 participants with unilateral nasolacrimal duct obstruction (NLDO) were enrolled at 22 clinical centers. During the same period, 57 participants were recruited with bilateral nasolacrimal duct obstruction (NLDO), however, these participants are not included in the analyses reported herein.
Participant milestones
| Measure |
Immediate Office Probing - Participants With Unilateral NLDO
Probing to be performed in the office setting using topical anesthesia and infant restraint. Probing to be performed either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
Deferred Facility Probing - Participants With Unilateral NLDO
Probing to be performed in a surgical facility under general anesthesia within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
81
|
|
Overall Study
6-Month Visit
|
73
|
67
|
|
Overall Study
COMPLETED
|
75
|
71
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old
Baseline characteristics by cohort
| Measure |
Immediate Office Probing - Participants With Unilateral NLDO
n=82 Participants
Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
Deferred Facility Probing - Participants With Unilateral NLDO
n=81 Participants
Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.6 months
STANDARD_DEVIATION 1.2 • n=5 Participants
|
7.8 months
STANDARD_DEVIATION 1.3 • n=7 Participants
|
7.7 months
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Age, Customized
6 to <7 months
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Age, Customized
7 to <8 months
|
28 participants
n=5 Participants
|
20 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Age, Customized
8 to <9 months
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Age, Customized
9 to <10 months
|
14 participants
n=5 Participants
|
21 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
68 participants
n=5 Participants
|
66 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
81 participants
n=7 Participants
|
163 participants
n=5 Participants
|
|
Previous treatment for NLDO
Lacrimal massage and topical antibiotics
|
39 participants
n=5 Participants
|
36 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Previous treatment for NLDO
Lacrimal massage only
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Previous treatment for NLDO
Topical antibiotics only
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Previous treatment for NLDO
None
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Previous treatment for NLDO
Unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Epiphora
Present
|
63 participants
n=5 Participants
|
70 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Epiphora
Absent
|
19 participants
n=5 Participants
|
11 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Increased tear film
Present
|
79 participants
n=5 Participants
|
81 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Increased tear film
Absent
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Mucous discharge
Present
|
60 participants
n=5 Participants
|
63 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Mucous discharge
Absent
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 months of agePopulation: All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the primary outcome visit at 18 months of age were analyzed. The analysis followed the intent-to-treat principle.
Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.
Outcome measures
| Measure |
Immediate Office Probing - Participants With Unilateral NLDO
n=75 Participants
Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
Deferred Facility Probing - Participants With Unilateral NLDO
n=71 Participants
Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
|---|---|---|
|
Proportion of Participants With Treatment Success
|
0.92 proportion of participants
|
0.82 proportion of participants
|
PRIMARY outcome
Timeframe: Randomization to 18 months of agePopulation: All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.
Total cost of treatment including the cost of an initial office consultation and all surgeries received (i.e. initial surgeries and reoperations) and medications prescribed for NLDO between randomization and the 18 months of age visit. Estimates of treatment costs were obtained primarily from the 2011 Medicare Fee Schedules.
Outcome measures
| Measure |
Immediate Office Probing - Participants With Unilateral NLDO
n=75 Participants
Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
Deferred Facility Probing - Participants With Unilateral NLDO
n=71 Participants
Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
|---|---|---|
|
Cost of Treatment
|
562 US dollars
Interval 141.0 to 2597.0
|
701 US dollars
Interval 141.0 to 2794.0
|
SECONDARY outcome
Timeframe: Randomization to 18 months of age.Population: All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.
Months of NLDO symptoms between randomization and 18 months of age. When resolution of NLDO occurred without surgery, the time of resolution was estimated as the midpoint between randomization and the first time point at which symptoms/signs were reported as absent (i.e. 3-month phone call, 6-month visit, or 18 months of age visit) without a subsequent report of symptoms/signs. For patients who underwent successful surgery, months of symptoms was estimated as months between randomization and the surgery. Patients who had clinical signs present at the 18 month of age visit were considered to have had symptoms present since randomization.
Outcome measures
| Measure |
Immediate Office Probing - Participants With Unilateral NLDO
n=75 Participants
Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
Deferred Facility Probing - Participants With Unilateral NLDO
n=71 Participants
Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
|---|---|---|
|
Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age
|
1.8 months of symptoms
Interval 0.0 to 12.0
|
4.8 months of symptoms
Interval 1.5 to 12.0
|
SECONDARY outcome
Timeframe: Randomization to 6 monthsPopulation: All participants who had unilateral nasolacrimal duct obstruction at baseline, who were randomized to the deferred facility probing group, and who completed the 6-month visit (timed from randomization). The analysis followed the intent to treat principle.
Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon unmasked examination 6 months after randomization. Participants who were operated before the 6-month visit were considered treatment failures.
Outcome measures
| Measure |
Immediate Office Probing - Participants With Unilateral NLDO
n=67 Participants
Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
Deferred Facility Probing - Participants With Unilateral NLDO
Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
|---|---|---|
|
Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery
|
0.66 proportion of participants
Interval 0.54 to 0.76
|
—
|
SECONDARY outcome
Timeframe: Randomization to 6 monthsPopulation: Participants randomized to immediate office probing who underwent office probing.
The proportion of immediate office group participants whose office probing was successful when assessed 6 months after randomization. Office probing success was defined as absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) 6 months after randomization and no reoperation.
Outcome measures
| Measure |
Immediate Office Probing - Participants With Unilateral NLDO
n=72 Participants
Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
Deferred Facility Probing - Participants With Unilateral NLDO
Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
|
|---|---|---|
|
Proportion of Participants With Office Probing Success 6 Months After Randomization
|
0.83 proportion with treatment success
Interval 0.73 to 0.9
|
—
|
Adverse Events
Immediate Office Probing - Participants With Unilateral NLDO
Deferred Facility Probing - Participants With Unilateral NLDO
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ray Kraker, Director of PEDIG Coordinating Center
Jaeb Center for Health Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place