Choroidal ThicknessNCT03160690
Changes in Choroidal Thickness After Non Penetrating Deep Sclerectomy
An observational study of Choroidal Thickness and Open Angle Glaucoma, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
Prospective and observational study to determine if choroidal thickness increases after non penetrating deep sclerectomy in patients with open angle glaucoma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Choroidal Thickness, Open Angle Glaucoma, Non Penetrating Deep Sclerectomy
- What is being tested?
- Non penetrating deep sclerectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jun 2017to 17 May 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with progressive open angle glaucoma although topical treatment with indication for non penetrating deep sclerectomy
Who may be able to join
- Progressive Primary Open Angle Glaucoma
Who cannot join
- Age under 18yrs
- Myopia or Hyperopia higher than -6D or +6D
- Secondary glaucoma
- Ocular surgery other than cataract
- Other ocular pathology
Trial locations and contacts
1 site in 1 country.
Spain1 site
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Sandra Gómez Sánchez, MD, 0034934978919, gomezsanchez.s@gmail.com
About this study
Prospective and observational study to determine if choroidal thickness increases after non penetrating deep sclerectomy in patients with open angle glaucoma
- Being tested
- Non penetrating deep sclerectomy
- Keywords
- Choroidal thickness, Open Angle Glaucoma, Non penetrating deep sclerectomy
- 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.
Non penetrating deep sclerectomyProcedure or surgery
Non penetrating deep sclerectomy for open angle glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Choroidal thickness
Choroidal thickness measured by optic coherence tomography
Measured: before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy
Change in Intraocular pressure
mmHg
Measured: before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start17 Jun 2017 (estimated)
- Primary completion17 Nov 2017 (estimated)
- Study completion17 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal ThicknessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pau Romera Romero, Jorge Loscos Arenas, Nevena Romanic Bubalo, Jordi Castellví Manent
- Responsible party
- Principal investigator, Sandra Gómez Sánchez, Germans Trias i Pujol Hospital
- Investigators
- Sandra Gómez Sánchez, MD, Principal investigator, Germans Trias i Pujol HospitalPau Romera Romero, MD, Principal investigator, Germans Trias i Pujol HospitalJorge Loscos Arenas, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160690
- Sponsor's protocol ID
- OFT-ENP-2017-03
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Choroidal Thickness After Non Penetrating Deep Sclerectomy
- ClinicalTrials.gov ID
- NCT03160690
- Acronym / sponsor ID
- OFT-ENP-2017-03
- Keywords
- Choroidal thickness, Open Angle Glaucoma, Non penetrating deep sclerectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Pau Romera Romero, Jorge Loscos Arenas, Nevena Romanic Bubalo, Jordi Castellví Manent
- Study start
- 17 Jun 2017 (estimated)
- Primary completion
- 17 Nov 2017 (estimated)
- Study completion
- 17 May 2018 (estimated)
- First posted
- 19 May 2017 (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.
Prospective and observational study to determine if choroidal thickness increases after non penetrating deep sclerectomy in patients with open angle glaucoma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with progressive open angle glaucoma although topical treatment with indication for non penetrating deep sclerectomy
Key inclusion criteria (1 listed)
- Progressive Primary Open Angle Glaucoma
Key exclusion criteria (5 listed)
- Age under 18yrs
- Myopia or Hyperopia higher than -6D or +6D
- Secondary glaucoma
- Ocular surgery other than cataract
- Other ocular pathology
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 |
|---|---|---|
| Non penetrating deep sclerectomyNon penetrating deep sclerectomy for open angle glaucoma | Procedure or surgery | – |
Primary outcome
Change in Choroidal thickness
Time frame: before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy
Choroidal thickness measured by optic coherence tomography
Change in Intraocular pressure
Time frame: before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy
mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Individual participant dataSharing planned: No
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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.
Sandra Gómez Sánchez, MD principal investigator
Germans Trias i Pujol Hospital
Pau Romera Romero, MD principal investigator
Germans Trias i Pujol Hospital
Jorge Loscos Arenas, PhD principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Thickness and Open Angle Glaucoma, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 5 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 19 May 2017. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Gómez Sánchez, MD (0034934978919, gomezsanchez.s@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Choroidal thickness (time frame: before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy). The study lists 2 primary outcomes in all. 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 19 May 2017.