GlaucomaNCT00595855
A Comparison Between Deep Sclerectomy and Trabeculectomy
A study testing trabeculectomy and deep sclerectomy in people with Glaucoma, run by University of Parma at 1 site in Italy.
Trial summary
Patients affected by medically uncontrolled open angle glaucoma will be randomised to either a non penetrating procedure (deep sclerectomy) or conventional trabeculectomy. The longterm efficacy (i.e. IOP w/out therapy) and safety (i.e. visual acuity, visual field stability and co-morbidities) will be evaluated. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- trabeculectomy and deep sclerectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Oct 1997to Dec 2006
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Angle wide open
- Age > 65 yrs
- IOP > 23 and < 30 mmHg (average of the two highest readings of the daily IOP phasing)
- Topical beta blocker in fellow eye
- At least two medications in use + previous ALT
- MD < 20 dB (HFA 24-2 full threshold)
- LOCSII < C1-N1-P0
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial
Patients affected by medically uncontrolled open angle glaucoma will be randomised to either a non penetrating procedure (deep sclerectomy) or conventional trabeculectomy. The longterm efficacy (i.e. IOP w/out therapy) and safety (i.e. visual acuity, visual field stability and co-morbidities) will be evaluated.
Read the detailed description
Prospective 7-year randomised investigator -masked clinical trial 79 eyes (79 patients) enrolled randomised to surgery by PEX and previous pilocarpine use Deep sclerectomy n = 41 Trabeculectomy n = 38 Estimated DS : TE success = 1:3 10% attrition ; power = 90%, alpha = 5%
Methods and evaluation of outcomes:
- IOP: average of the two highest readings of the IOP phasing (6 readings)
- VA: LogMAR (ETDRS chart)
- Lens: LOCSII (slit lamp classification), worsening = one step progression confirmed at two visits study visits: every 4 months
- Conditions
- Glaucoma
- Being tested
- trabeculectomy, deep sclerectomy
- Keywords
- glaucoma, surgery, non penetrating procedures, cataract
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabeculectomyProcedure or surgery
Cairns-like trabeculectomy, limbus based, with 5_FU supplementation and argon laser suturelysis
deep sclerectomyProcedure or surgery
deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)
| Study group | Role | What they receive |
|---|---|---|
| TE | Active comparator | trabeculectomy Receives: Procedure: trabeculectomy |
| DS | Experimental | deep sclerectomy Receives: Procedure: deep sclerectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)
Measured: 7 years
Secondary outcomes (1)
(a) LogMAR visual acuity, (b) number of cataract extraction procedures
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startOct 1997
- Primary completionJan 2007
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Investigators
- Gandolfi Stefano, MD, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595855
- Sponsor's protocol ID
- PARMASURG001
- Status last verified
- Jan 2008
- First submitted
- 7 Jan 2008
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT00595855
- Acronym / sponsor ID
- PARMASURG001
- Conditions
- Glaucoma
- Keywords
- glaucoma, surgery, non penetrating procedures, cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Oct 1997
- Primary completion
- Jan 2007 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 16 Jan 2008 (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.
Patients affected by medically uncontrolled open angle glaucoma will be randomised to either a non penetrating procedure (deep sclerectomy) or conventional trabeculectomy. The longterm efficacy (i.e. IOP w/out therapy) and safety (i.e. visual acuity, visual field stability and co-morbidities) will be evaluated.
Detailed description
Prospective 7-year randomised investigator -masked clinical trial 79 eyes (79 patients) enrolled randomised to surgery by PEX and previous pilocarpine use Deep sclerectomy n = 41 Trabeculectomy n = 38 Estimated DS : TE success = 1:3 10% attrition ; power = 90%, alpha = 5%
Methods and evaluation of outcomes:
- IOP: average of the two highest readings of the IOP phasing (6 readings)
- VA: LogMAR (ETDRS chart)
- Lens: LOCSII (slit lamp classification), worsening = one step progression confirmed at two visits study visits: every 4 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TE | Active comparator | Procedure: trabeculectomytrabeculectomy |
| DS | Experimental | Procedure: deep sclerectomydeep sclerectomy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Angle wide open
- Age > 65 yrs
- IOP > 23 and < 30 mmHg (average of the two highest readings of the daily IOP phasing)
- Topical beta blocker in fellow eye
- At least two medications in use + previous ALT
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| trabeculectomyCairns-like trabeculectomy, limbus based, with 5_FU supplementation and argon laser suturelysis | Procedure or surgery | TE |
| deep sclerectomydeep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed) | Procedure or surgery | DS |
Primary outcome
intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)
Time frame: 7 years
1 secondary outcome
(a) LogMAR visual acuity, (b) number of cataract extraction procedures
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
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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.
Gandolfi Stefano, MD principal investigator
University of Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trabeculectomy and deep sclerectomy in people with Glaucoma, run by University of Parma at 1 site in Italy.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 16 Jan 2008. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 without therapy (% of eyes within pre-selected cut-off limits) (time frame: 7 years). 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 16 Jan 2008.