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Trial record 28 of 2645 for:    ( Map: Idaho, United States )

Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old (NLD3)

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ClinicalTrials.gov Identifier: NCT00780741
Recruitment Status : Completed
First Posted : October 28, 2008
Results First Posted : November 12, 2012
Last Update Posted : June 24, 2016
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Nasolacrimal Duct Obstruction
Interventions Procedure: Immediate Office Probing
Procedure: Deferred Facility Probing
Enrollment 220
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title Immediate Office Probing - Participants With Unilateral NLDO Deferred Facility Probing - Participants With Unilateral NLDO
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 82 [1] 81 [1]
6-Month Visit 73 [2] 67 [2]
Completed 75 [3] 71 [3]
Not Completed 7 10
[1]
randomized
[2]
6 months (±2 weeks) timed from randomization
[3]
18 months of age (±4 weeks)
Arm/Group Title Immediate Office Probing - Participants With Unilateral NLDO Deferred Facility Probing - Participants With Unilateral NLDO Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 82 81 163
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 82 participants 81 participants 163 participants
7.6  (1.2) 7.8  (1.3) 7.7  (1.2)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
6 to <7 months 25 27 52
7 to <8 months 28 20 48
8 to <9 months 15 13 28
9 to <10 months 14 21 35
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
Female
32
  39.0%
42
  51.9%
74
  45.4%
Male
50
  61.0%
39
  48.1%
89
  54.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
White 68 66 134
African American 3 6 9
Hispanic or Latino 10 7 17
Asian 1 1 2
More than one race 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 82 participants 81 participants 163 participants
82 81 163
Previous treatment for NLDO  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
Lacrimal massage and topical antibiotics 39 36 75
Lacrimal massage only 18 15 33
Topical antibiotics only 10 14 24
None 15 15 30
Unknown 0 1 1
Epiphora  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
Present 63 70 133
Absent 19 11 30
Increased tear film  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
Present 79 81 160
Absent 3 0 3
Mucous discharge  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
Present 60 63 123
Absent 22 18 40
1.Primary Outcome
Title Proportion of Participants With Treatment Success
Hide Description Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.
Time Frame 18 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Immediate Office Probing - Participants With Unilateral NLDO Deferred Facility Probing - Participants With Unilateral NLDO
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 75 71
Measure Type: Number
Unit of Measure: proportion of participants
0.92 0.82
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Office Probing - Participants With Unilateral NLDO, Deferred Facility Probing - Participants With Unilateral NLDO
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Point estimate on mean difference
Comments Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.01 to 0.21
Estimation Comments Mean difference calculated as the proportion with success in immediate group minus proportion with success in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.
2.Primary Outcome
Title Cost of Treatment
Hide Description 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.
Time Frame Randomization to 18 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Immediate Office Probing - Participants With Unilateral NLDO Deferred Facility Probing - Participants With Unilateral NLDO
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 75 71
Mean (Full Range)
Unit of Measure: US dollars
562
(141 to 2597)
701
(141 to 2794)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Office Probing - Participants With Unilateral NLDO, Deferred Facility Probing - Participants With Unilateral NLDO
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Point estimate on mean difference
Comments Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -139
Confidence Interval (2-Sided) 95%
-377 to 94
Estimation Comments Mean difference calculated as the average cost in immediate group minus average cost in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.
3.Secondary Outcome
Title Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age
Hide Description 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.
Time Frame Randomization to 18 months of age.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Immediate Office Probing - Participants With Unilateral NLDO Deferred Facility Probing - Participants With Unilateral NLDO
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 75 71
Mean (Full Range)
Unit of Measure: months of symptoms
1.8
(0.0 to 12.0)
4.8
(1.5 to 12.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Office Probing - Participants With Unilateral NLDO, Deferred Facility Probing - Participants With Unilateral NLDO
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Point estimate on mean difference
Comments Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-4.0 to -1.8
Estimation Comments Mean difference calculated as the average months of symptoms in immediate group minus average months of symptoms in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.
4.Secondary Outcome
Title Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery
Hide Description 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.
Time Frame Randomization to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Deferred Facility Probing - Participants With Unilateral NLDO
Hide Arm/Group Description:
Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.66
(0.54 to 0.76)
5.Secondary Outcome
Title Proportion of Participants With Office Probing Success 6 Months After Randomization
Hide Description 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.
Time Frame Randomization to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to immediate office probing who underwent office probing.
Arm/Group Title Immediate Office Probing - Participants With Unilateral NLDO
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion with treatment success
0.83
(0.73 to 0.90)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate Office Probing - Participants With Unilateral NLDO Deferred Facility Probing - Participants With Unilateral NLDO
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Immediate Office Probing - Participants With Unilateral NLDO Deferred Facility Probing - Participants With Unilateral NLDO
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Immediate Office Probing - Participants With Unilateral NLDO Deferred Facility Probing - Participants With Unilateral NLDO
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/81 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immediate Office Probing - Participants With Unilateral NLDO Deferred Facility Probing - Participants With Unilateral NLDO
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/81 (0.00%) 

Conclusions not definitive--would need larger sample size.

Participants with bilateral NLDO excluded, so results not generalizable to bilateral cases.

Actual costs may vary by region and payer.

Did not include costs of follow up visits.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ray Kraker, Director of PEDIG Coordinating Center
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
EMail: rkraker@jaeb.org
Layout table for additonal information
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00780741     History of Changes
Other Study ID Numbers: NEI-142
2U10EY011751 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 2008
First Posted: October 28, 2008
Results First Submitted: August 23, 2012
Results First Posted: November 12, 2012
Last Update Posted: June 24, 2016