Normal Tension GlaucomaDSTRENTGNCT05371977
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
A study testing Trabeculectomy and Deep Sclerectomy in people with Normal Tension Glaucoma, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma. Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Normal Tension 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
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 31 May 2022to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
- Glaucoma unstable with current medication assessed by a glaucoma specialist
Who cannot join
- Secondary Glaucoma e.g. due to previous injury or uveitis
- Exfoliation syndrome
- Pigment dispersion syndrome
- Previous transscleral or endoscopic cyclophotocoagulation
- Previous other glaucoma surgery
- Previous retinal detachment
Show all 15Show fewer
- Previous intraocular surgery like vitrectomy and other retinal surgery
- Wet age-related macular degeneration
- Diabetic retonopathy
- Previous corneal transplant or previous refractive surgery
- Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars
- The patient does not want to participate in the study
- The patient does not speak Finnish, Swedish or English
- Dementia
- Only eye with vision worse than 20/200 or loss of central visual field
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki, 00990
Nina Lindbohm, MD, PhD, +358 9 4711, nina.lindbohm@hus.fi
About this study
The purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma.
Read the detailed description
Subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.
- Conditions
- Normal Tension Glaucoma
- Being tested
- Trabeculectomy, Deep Sclerectomy
- Medical subject headings
- Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabeculectomyProcedure or surgery
trabeculectomy glaucoma surgery
Deep SclerectomyProcedure or surgery
deep sclerectomy glaucoma surgery
| Study group | Role | What they receive |
|---|---|---|
| Deep sclerectomy | Experimental | Not described Receives: Procedure: Deep Sclerectomy |
| Trabeculectomy | Active comparator | Not described Receives: Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications
Measured: One year
Secondary outcomes (1)
Success Rate
Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start31 May 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Tension 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
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Lindbohm, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371977
- Sponsor's protocol ID
- DSTRENTG
- Acronym
- DSTRENTG
- Status last verified
- Mar 2024
- First submitted
- 2 May 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
- ClinicalTrials.gov ID
- NCT05371977
- Acronym / sponsor ID
- DSTRENTG / DSTRENTG
- Conditions
- Normal Tension Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 12 May 2022 (actual)
- 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 this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma.
Detailed description
Subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep sclerectomy | Experimental | Procedure: Deep Sclerectomy |
| Trabeculectomy | Active comparator | Procedure: Trabeculectomy |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
- Glaucoma unstable with current medication assessed by a glaucoma specialist
Key exclusion criteria (15 listed)
- Secondary Glaucoma e.g. due to previous injury or uveitis
- Exfoliation syndrome
- Pigment dispersion syndrome
- Previous transscleral or endoscopic cyclophotocoagulation
- Previous other glaucoma 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 |
|---|---|---|
| Trabeculectomytrabeculectomy glaucoma surgery | Procedure or surgery | Trabeculectomy |
| Deep Sclerectomydeep sclerectomy glaucoma surgery | Procedure or surgery | Deep sclerectomy |
Primary outcome
Success Rate
Time frame: One year
Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications
1 secondary outcome
Success Rate
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
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 Normal Tension Glaucoma, run by Helsinki University Central Hospital at 1 site in Finland.
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 3 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 15 Mar 2024. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: One year). 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 15 Mar 2024.