Open-Angle GlaucomaPhase 2/3GCNCT01511094
Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
A Phase 2/3 study testing Goniocurettage in people with Open-Angle Glaucoma and Surgery, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as a first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with good vision. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Surgery
- What is being tested?
- Goniocurettage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Jan 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disc and/or visual field findings consistent with Primary Open Angle Glaucoma
- Uncontrolled intraocular pressure (≥21 mm Hg) or progressive glaucomatous neuropathy despite maximum tolerated medical therapy
- 40 years old or over
- Visual acuity higher than 0.2
- Open angles (greater or equal to Shaffer grade II)
Who cannot join
- Previous ocular surgery
- History of glaucoma laser treatment
- History of ocular trauma
- Cyclodestructive procedures
- Corneal edema or opacities
- Endothelial decompensation
Show all 11Show fewer
- History of uveitis
- Secondary glaucoma
- neovascularization of the iris or angle
- Congenital anterior segment abnormalities
- Anatomically confusing angles without clear definition of the scleral spur or meshwork and inability to maintain follow-up
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
About this study
The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as a first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with good vision.
Read the detailed description
A prospective study in 33 eyes (32 patients) with uncontrolled open angle glaucoma under clinical treatment. The trabecular tissue was scraped away from the angle (goniocurettage) in about 100 degrees by means of an instrument similar to a microchalazion curette. The goniocurettage was done under direct visualization of the angle through a gonioscopy lens (Swan-Jacob) and a surgical microscope. Using the 17.0 SPSS software the investigators compared the intraocular pressure, the numbers of antiglaucomatous medications, the best correct visual acuity, the development of cataract, the central corneal thickness,the impact on the visual field, the impact on the optic nerve head and the central corneal endothelial cell density before and after the goniocurettage, and the intra and post operative complications.
- Conditions
- Open-Angle Glaucoma, Surgery
- Being tested
- Goniocurettage
- Keywords
- ab-interno trabeculectomy,, intraocular pressure,, open angle glaucoma, trabeculectomy, Goniocurettage, Non-Filtering Surgery
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoniocurettageProcedure or surgery
Also called Ab interno glaucoma precedure, Open angle glacuoma surgery, Non filtering glaucoma procedure
Ab interno surgery consisting on scraped away the trabecular tissue from the angle (goniocurettage) removing segments of pathologically altered trabecular meshwork from the scleral sulcus
| Study group | Role | What they receive |
|---|---|---|
| Eye Surgery | Experimental | Goniocurettage was used to treat open angle glaucoma patients Receives: Procedure: Goniocurettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra Ocular Pressure
The mean of at least three measures at 8:00 am two weeks before surgery. After intervention, the Intra Ocular Pressure was measured on the day after, one week after, two weeks after and every month at the same time until the end of the study (an expected average of 20 months).
Measured: Change from Baseline in Intra Ocular Pressure at 20 months
Secondary outcomes (3)
Central Corneal Thickness
Measured: Two weeks before, six months after and one year after intervention
Central corneal endothelial cell density
Measured: Two weeks before, six months after intervention and one year after intervention
Best correct visual acuity
Measured: Two weeks before, six months after and one year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiago Tomaz de Souza, Federal University of Minas Gerais
- Investigators
- Tiago T Souza, MD, Principal investigator, Federal University of Minas GeraisSebastiao Cronemberger, PhD, Study director, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511094
- Sponsor's protocol ID
- Gonio-32
- Acronym
- GC
- Status last verified
- Jan 2012
- First submitted
- 14 Oct 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacobi PC, Dietlein TS, Krieglstein GK. Technique of goniocurettage: a potential treatment for advanced chronic open angle glaucoma. Br J Ophthalmol. 1997 Apr;81(4):302-7. doi: 10.1136/bjo.81.4.302.
PubMed 9215060Jacobi PC, Dietlein TS, Krieglstein GK. Goniocurettage for removing trabecular meshwork: clinical results of a new surgical technique in advanced chronic open-angle glaucoma. Am J Ophthalmol. 1999 May;127(5):505-10. doi: 10.1016/s0002-9394(98)00448-6.
PubMed 10334341Jacobi PC, Dietlein TS, Krieglstein GK. Microendoscopic trabecular surgery in glaucoma management. Ophthalmology. 1999 Mar;106(3):538-44. doi: 10.1016/S0161-6420(99)90113-6.
PubMed 10080211Johnson DH, Johnson M. How does nonpenetrating glaucoma surgery work? Aqueous outflow resistance and glaucoma surgery. J Glaucoma. 2001 Feb;10(1):55-67. doi: 10.1097/00061198-200102000-00011.
PubMed 11219641Minckler D, Baerveldt G, Ramirez MA, Mosaed S, Wilson R, Shaarawy T, Zack B, Dustin L, Francis B. Clinical results with the Trabectome, a novel surgical device for treatment of open-angle glaucoma. Trans Am Ophthalmol Soc. 2006;104:40-50.
PubMed 17471324
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
- ClinicalTrials.gov ID
- NCT01511094
- Acronym / sponsor ID
- GC / Gonio-32
- Conditions
- Open-Angle Glaucoma, Surgery
- Keywords
- ab-interno trabeculectomy,, intraocular pressure,, open angle glaucoma, trabeculectomy, Goniocurettage, Non-Filtering Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jan 2012 (estimated)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as a first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with good vision.
Detailed description
A prospective study in 33 eyes (32 patients) with uncontrolled open angle glaucoma under clinical treatment. The trabecular tissue was scraped away from the angle (goniocurettage) in about 100 degrees by means of an instrument similar to a microchalazion curette. The goniocurettage was done under direct visualization of the angle through a gonioscopy lens (Swan-Jacob) and a surgical microscope. Using the 17.0 SPSS software the investigators compared the intraocular pressure, the numbers of antiglaucomatous medications, the best correct visual acuity, the development of cataract, the central corneal thickness,the impact on the visual field, the impact on the optic nerve head and the central corneal endothelial cell density before and after the goniocurettage, and the intra and post operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye Surgery | Experimental | Procedure: GoniocurettageGoniocurettage was used to treat open angle glaucoma patients |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Disc and/or visual field findings consistent with Primary Open Angle Glaucoma
- Uncontrolled intraocular pressure (≥21 mm Hg) or progressive glaucomatous neuropathy despite maximum tolerated medical therapy
- 40 years old or over
- Visual acuity higher than 0.2
- Open angles (greater or equal to Shaffer grade II)
Key exclusion criteria (11 listed)
- Previous ocular surgery
- History of glaucoma laser treatment
- History of ocular trauma
- Cyclodestructive procedures
- Corneal edema or opacities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GoniocurettageAlso: Ab interno glaucoma precedure, Open angle glacuoma surgery, Non filtering glaucoma procedureAb interno surgery consisting on scraped away the trabecular tissue from the angle (goniocurettage) removing segments of pathologically altered trabecular meshwork from the scleral sulcus | Procedure or surgery | Eye Surgery |
Primary outcome
Intra Ocular Pressure
Time frame: Change from Baseline in Intra Ocular Pressure at 20 months
The mean of at least three measures at 8:00 am two weeks before surgery. After intervention, the Intra Ocular Pressure was measured on the day after, one week after, two weeks after and every month at the same time until the end of the study (an expected average of 20 months).
3 secondary outcomes
Central Corneal Thickness
Time frame: Two weeks before, six months after and one year after intervention
Central corneal endothelial cell density
Time frame: Two weeks before, six months after intervention and one year after intervention
Best correct visual acuity
Time frame: Two weeks before, six months after and one year after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
- Background: PubMed 9215060Jacobi PC, Dietlein TS, Krieglstein GK. Technique of goniocurettage: a potential treatment for advanced chronic open angle glaucoma. Br J Ophthalmol. 1997 Apr;81(4):302-7. doi: 10.1136/bjo.81.4.302.
- Background: PubMed 10334341Jacobi PC, Dietlein TS, Krieglstein GK. Goniocurettage for removing trabecular meshwork: clinical results of a new surgical technique in advanced chronic open-angle glaucoma. Am J Ophthalmol. 1999 May;127(5):505-10. doi: 10.1016/s0002-9394(98)00448-6.
- Background: PubMed 10080211Jacobi PC, Dietlein TS, Krieglstein GK. Microendoscopic trabecular surgery in glaucoma management. Ophthalmology. 1999 Mar;106(3):538-44. doi: 10.1016/S0161-6420(99)90113-6.
- Background: PubMed 11219641Johnson DH, Johnson M. How does nonpenetrating glaucoma surgery work? Aqueous outflow resistance and glaucoma surgery. J Glaucoma. 2001 Feb;10(1):55-67. doi: 10.1097/00061198-200102000-00011.
- Background: PubMed 17471324Minckler D, Baerveldt G, Ramirez MA, Mosaed S, Wilson R, Shaarawy T, Zack B, Dustin L, Francis B. Clinical results with the Trabectome, a novel surgical device for treatment of open-angle glaucoma. Trans Am Ophthalmol Soc. 2006;104:40-50.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiago T Souza, MD principal investigator
Federal University of Minas Gerais
Sebastiao Cronemberger, PhD study director
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Goniocurettage in people with Open-Angle Glaucoma and Surgery, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra Ocular Pressure (time frame: Change from Baseline in Intra Ocular Pressure at 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01511094, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.