Trial · NCT00666237

Primary Tube Versus Trabeculectomy Study

NCT00666237, Phase 4, Completed, University of Miami; results first posted 2022-10-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Primary Tube Versus Trabeculectomy Study. Trials, record NCT00666237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00666237

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Primary Tube Versus Trabeculectomy Study
NCT number: NCT00666237
Status: Completed
Phases: Phase 4
Enrollment: 242 participants, actual
Lead sponsor: University of Miami
Conditions: Glaucoma
Interventions: Tube shunt surgery, Trabeculectomy, Mitomycin C
First posted: 2008-04-24
Last updated: 2022-10-19
Results first posted: 2022-10-19

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Surgical Failure	Up to 5 years	Surgical failure is defined as: 1. Inadequate Intraocular Pressure (IOP) Reduction (IOP \> 21 mmHg or reduced \< 20% below baseline on 2 consecutive follow-up visits after 3 months) 2. Reoperation for glaucoma 3. Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) 4. Loss of light perception vision
Secondary	Intraocular Pressure	At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years	Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen.
Secondary	Number of Participants With Reported Postoperative Complications	Up to 5 years	Number of participants with early and late postoperative complications will be reported as per treating physician assessment
Secondary	Visual Acuity Using a Snellen Chart	At Baseline, At 5 years	Visual acuity will be measured using a Snellen chart on logMAR (Logarithm of Minimal Angle of Resolution) scale. Letter-by letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Secondary	Visual Acuity as Measured Using EDTRS Chart	At baseline, At 5 years	Visual acuity will be reported as the number of correctly identified letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) chart. Total score ranges from 0-100 with the higher score indicating better visual acuity.
Secondary	Visual Field	Up to 5 years	Visual fields will be measured using standard automated perimetry.
Secondary	Reoperation for Glaucoma	Up to 5 years	The number of participants requiring reoperation for glaucoma will be reported
Secondary	Number of Glaucoma Medications	At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years	The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Surgical Failure	Up to 5 years	The number of participants requiring glaucoma operations includes only those that had a failed surgery due to glaucoma reoperation.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Intraocular Pressure	At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years	Participants who underwent additional glaucoma surgery were censored from analysis after reoperation. Not all participants completed all visits to complete the IOP assessment.	mmHg	MEAN
SECONDARY	Number of Participants With Reported Postoperative Complications	Up to 5 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Visual Acuity Using a Snellen Chart	At Baseline, At 5 years	Not all participants were able to complete the 5 year follow up visit and assessments.	logMAR	MEAN
SECONDARY	Visual Acuity as Measured Using EDTRS Chart	At baseline, At 5 years	Not all participants were able to complete the 5 year follow up visit and assessments.	letters	MEAN
SECONDARY	Visual Field	Up to 5 years	No data is reported for this outcome as data can not be extracted from system despite exhausting all efforts to do so.
SECONDARY	Reoperation for Glaucoma	Up to 5 years	The number of participants requiring glaucoma operations includes those that had a failed surgery due to glaucoma reoperation, as well as, other patients who failed because of inadequate intraocular pressure reduction and subsequently underwent glaucoma surgery.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Glaucoma Medications	At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years	Participants who underwent additional glaucoma surgery were censored from analysis after reoperation. Not all participants completed all visits to complete assessment.	glaucoma medications used	MEAN

Source ClinicalTrials.gov

Results by group50

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Surgical Failure	Tube Shunt Surgery Group	Inadequate IOP reduction	31		Participants
Number of Participants With Surgical Failure	Trabeculectomy With Mitomycin C	Inadequate IOP reduction	23		Participants
Number of Participants With Surgical Failure	Tube Shunt Surgery Group	Reoperation for Glaucoma	18		Participants
Number of Participants With Surgical Failure	Trabeculectomy With Mitomycin C	Reoperation for Glaucoma	9		Participants
Number of Participants With Surgical Failure	Tube Shunt Surgery Group	Loss of light perception vision	0		Participants
Number of Participants With Surgical Failure	Trabeculectomy With Mitomycin C	Loss of light perception vision	1		Participants
Number of Participants With Surgical Failure	Tube Shunt Surgery Group	Persistent Hypotony	0		Participants
Number of Participants With Surgical Failure	Trabeculectomy With Mitomycin C	Persistent Hypotony	5		Participants
Intraocular Pressure	Tube Shunt Surgery Group	Intraocular Pressure: Baseline	23.3	Standard Deviation 4.9	mmHg
Intraocular Pressure	Trabeculectomy With Mitomycin C	Intraocular Pressure: Baseline	23.9	Standard Deviation 5.7	mmHg

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tube Shunt Surgery Group	125
Overall Study	STARTED	Trabeculectomy With Mitomycin C	117
Overall Study	COMPLETED	Tube Shunt Surgery Group	91
Overall Study	COMPLETED	Trabeculectomy With Mitomycin C	87
Overall Study	NOT COMPLETED	Tube Shunt Surgery Group	34
Overall Study	NOT COMPLETED	Trabeculectomy With Mitomycin C	30

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Shallow or flat anterior chamber	Eye disorders	Tube Shunt Surgery Group	15	125	15
other	Shallow or flat anterior chamber	Eye disorders	Trabeculectomy With Mitomycin C	15	117	15
other	Choroidal Effusion	Eye disorders	Tube Shunt Surgery Group	11	125	11
other	Choroidal Effusion	Eye disorders	Trabeculectomy With Mitomycin C	12	117	12
other	Wound Leak	Surgical and medical procedures	Tube Shunt Surgery Group	1	125	1
other	Wound Leak	Surgical and medical procedures	Trabeculectomy With Mitomycin C	13	117	13
other	Hyphema	Eye disorders	Tube Shunt Surgery Group	8	125	8
other	Hyphema	Eye disorders	Trabeculectomy With Mitomycin C	5	117	5
other	Encapsulated bleb	Eye disorders	Tube Shunt Surgery Group	13	125	13
other	Encapsulated bleb	Eye disorders	Trabeculectomy With Mitomycin C	26	117	26

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tube Shunt Surgery Group	5	125
Total, all-cause mortality	Trabeculectomy With Mitomycin C	5	117
Total, other adverse events	Tube Shunt Surgery Group	51	125
Total, other adverse events	Trabeculectomy With Mitomycin C	72	117
Total, serious adverse events	Tube Shunt Surgery Group	0	125
Total, serious adverse events	Trabeculectomy With Mitomycin C	0	117

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29248173	BACKGROUND	PubMed
29477688	RESULT	PubMed
31727428	RESULT	PubMed
32622848	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tube Shunt Surgery Group vs Trabeculectomy With Mitomycin C: Reoperation for Glaucoma	Trial comparisons
Tube Shunt Surgery Group vs Trabeculectomy With Mitomycin C: deaths from any cause	Trial comparisons
Tube Shunt Surgery Group vs Trabeculectomy With Mitomycin C: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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