Normal Tension GlaucomaECPNTGNCT04651530
Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma
A study testing Phaco and Phaco+ECP in people with Normal Tension Glaucoma and Cataract, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to assess whether endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone 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, Cataract
- What is being tested?
- Phaco and Phaco+ECP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 8 Dec 2020to 1 Dec 2026
- 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 stable with current medication assessed by a glaucoma specialist
- Clinically significant cataract
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
- Cataract due to eye injury or congenital cataract
Show all 18Show fewer
- Zonular weakness due to Marfan syndrome or other
- Previous retinal detachment
- 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 glaucoma progresses on current IOP
- 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 Hospital
Helsinki, 00029
Jukka AO Moilanen, MD, PhD, +358405820860, jukka.moilanen@hus.fi
About this study
The purpose of this study is to assess whether endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone in patients with normal tension glaucoma.
Read the detailed description
Subjects with normal tension glaucoma that is stable with current medication needing cataract surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having endoscopic cyclophotocoagulation performed in the same session with cataract surgery, or cataract surgery alone.
- Conditions
- Normal Tension Glaucoma, Cataract
- Being tested
- Phaco, Phaco+ECP
- Keywords
- endoscopic cyclophotocoagulation, ECP, Surgery
- Medical subject headings
- Low Tension Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoProcedure or surgery
phacoemulsification of cataract only
Phaco+ECPProcedure or surgery
Endoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract
| Study group | Role | What they receive |
|---|---|---|
| Phaco | Active comparator | Cataract surgery only Receives: Procedure: Phaco |
| Phaco+ECP | Experimental | Cataract surgery combined with endoscopic cyclophotocoagulation Receives: Procedure: Phaco+ECP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Succes rate
Success: Decrease in Intraocular Pressure (IOP) of 20 % or more or former level with fewer medications
Measured: One year postoperatively
Secondary outcomes (1)
Additional surgery
Comparison of the need for additional glaucoma surgery
Measured: Five years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start8 Dec 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mika Harju, Helsinki University Central Hospital
- Investigators
- Mika Harju, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651530
- Sponsor's protocol ID
- 876543
- Acronym
- ECPNTG
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma
- ClinicalTrials.gov ID
- NCT04651530
- Acronym / sponsor ID
- ECPNTG / 876543
- Conditions
- Normal Tension Glaucoma, Cataract
- Keywords
- endoscopic cyclophotocoagulation, ECP, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Dec 2020 (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 endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone in patients with normal tension glaucoma.
Detailed description
Subjects with normal tension glaucoma that is stable with current medication needing cataract surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having endoscopic cyclophotocoagulation performed in the same session with cataract surgery, or cataract surgery alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phaco | Active comparator | Procedure: PhacoCataract surgery only |
| Phaco+ECP | Experimental | Procedure: Phaco+ECPCataract surgery combined with endoscopic cyclophotocoagulation |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 stable with current medication assessed by a glaucoma specialist
- Clinically significant cataract
Key exclusion criteria (18 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 |
|---|---|---|
| Phacophacoemulsification of cataract only | Procedure or surgery | Phaco |
| Phaco+ECPEndoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract | Procedure or surgery | Phaco+ECP |
Primary outcome
Succes rate
Time frame: One year postoperatively
Success: Decrease in Intraocular Pressure (IOP) of 20 % or more or former level with fewer medications
1 secondary outcome
Additional surgery
Time frame: Five years postoperatively
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 22 Dec 2020.
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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.
Mika Harju, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phaco and Phaco+ECP in people with Normal Tension Glaucoma and Cataract, 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 4 inclusion and 18 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 22 Dec 2020. 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?
Contact Nina M Lindbohm, MD, PhD (+358505715668, nina.lindbohm@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Succes rate (time frame: One year postoperatively). 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 22 Dec 2020.