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Comparison · NCT00666237-sae

Tube Shunt Surgery Group vs Trabeculectomy With Mitomycin C: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Tube Shunt Surgery Group vs Trabeculectomy With Mitomycin C: serious adverse events. Trial comparisons, record NCT00666237-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00666237-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.000000000000000001730.0298wilson
Risk in group 2000.0318wilson
Risk difference, group 1 minus group 20-0.03180.0298newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Tube Shunt Surgery Group
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).~Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
0125EG000
Group 2Trabeculectomy With Mitomycin C
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C~Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.~Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
0117EG001

Harm

What it counts
Total, serious adverse events
Time frame
5 years

Source ClinicalTrials.gov

Trial

Title
Primary Tube Versus Trabeculectomy Study
NCT number
NCT00666237
Phases
PHASE4
Conditions
Glaucoma
Interventions
Tube shunt surgery, Trabeculectomy, Mitomycin C
Lead sponsor
University of Miami
Results first posted
2022-10-19

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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