Primary Open Angle GlaucomaNCT00346931
Phacotrabeculotomy Versus CCI+Phaco in Patients With Borderline Control of Intraocular Pressure
A study testing Phacoemulsification, implantation of intraocular lens and Phacoemulsification, Implantation of IOL, trabeculotomy in people with Primary Open Angle Glaucoma and Pseudoexfoliative Glaucoma, run by Medical University of Vienna.
Trial summary
The purpose of the study is to determine whether combined cataract and glaucoma surgery (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery alone in patients with borderline control of intraocular pressure. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma
- What is being tested?
- Phacoemulsification, implantation of intraocular lens and Phacoemulsification, Implantation of IOL, trabeculotomy
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Jun 2007
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of Primary Open Angle or Pseudoexfoliative Glaucoma and Cataract
Who cannot join
- Other glaucoma than POAG or PEX-Glaucoma
- Medically uncontrolled Glaucoma:
- IOP > 24 mmHg with two topical medications IOP > 21 mmHg with three topical medications
- IOP < 18 mmHg with two topical medications IOP < 16 mmHg with three topical medications
- previous ocular surgery
- other ocular pathologies affecting visual acuity
- disorders of immune system
About this study
Official title: Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure
The purpose of the study is to determine whether combined cataract and glaucoma surgery (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery alone in patients with borderline control of intraocular pressure.
- Being tested
- Phacoemulsification, implantation of intraocular lens, Phacoemulsification, Implantation of IOL, trabeculotomy
- Keywords
- glaucoma, cataract, surgery, intraocular pressure, phacoemulsification, trabeculotomy
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification, implantation of intraocular lensProcedure or surgery
Phacoemulsification, Implantation of IOL, trabeculotomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication
Secondary outcomes (10)
Number of Patients with Constant Intraocular Pressure <18 mmHg without medication
Number of Patients with Constant Intraocular Pressure <21 mmHg with/without medication
Number of Patients needing surgical retreatment
Number of Patients with failure of surgical retreatment
Mean IOP after 1 and 2 years
Mean number of medication after 1 and 2 years
Number of intraoperative complications
comparison of postoperative complications between the groups
Visual acuity
decrease in perimetry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startDec 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Clemens Vass, Univ.Prof.Dr.med.univ., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346931
- Sponsor's protocol ID
- CCI-PTO-2004-AKH
- Status last verified
- Jun 2006
- First submitted
- 29 Jun 2006
- Last updated
- 23 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure
- ClinicalTrials.gov ID
- NCT00346931
- Acronym / sponsor ID
- CCI-PTO-2004-AKH
- Keywords
- glaucoma, cataract, surgery, intraocular pressure, phacoemulsification, trabeculotomy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 4 Jul 2006 (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 purpose of the study is to determine whether combined cataract and glaucoma surgery (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery alone in patients with borderline control of intraocular pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical Diagnosis of Primary Open Angle or Pseudoexfoliative Glaucoma and Cataract
Key exclusion criteria (7 listed)
- Other glaucoma than POAG or PEX-Glaucoma
- Medically uncontrolled Glaucoma:
- IOP > 24 mmHg with two topical medications IOP > 21 mmHg with three topical medications
- IOP < 18 mmHg with two topical medications IOP < 16 mmHg with three topical medications
- previous ocular surgery
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 |
|---|---|---|
| Phacoemulsification, implantation of intraocular lens | Procedure or surgery | – |
| Phacoemulsification, Implantation of IOL, trabeculotomy | Procedure or surgery | – |
Primary outcome
Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication
10 secondary outcomes
Number of Patients with Constant Intraocular Pressure <18 mmHg without medication
Number of Patients with Constant Intraocular Pressure <21 mmHg with/without medication
Number of Patients needing surgical retreatment
Number of Patients with failure of surgical retreatment
Mean IOP after 1 and 2 years
Mean number of medication after 1 and 2 years
Number of intraoperative complications
comparison of postoperative complications between the groups
Visual acuity
decrease in perimetry
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
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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.
Clemens Vass, Univ.Prof.Dr.med.univ. principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification, implantation of intraocular lens and Phacoemulsification, Implantation of IOL, trabeculotomy in people with Primary Open Angle Glaucoma and Pseudoexfoliative Glaucoma, run by Medical University of Vienna.
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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was stopped early. 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?
Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2010.