Proliferative Diabetic RetinopathyPhase 4pascalNCT00682240
Morphological and Functional Retinal Changes Following Retinal Photocoagulation
A Phase 4 study testing laser treatment with PASCAL® and laser treatment with conventional laser system in people with Proliferative Diabetic Retinopathy and Macular Edema, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Imaging of retinal morphological changes with time secondary to laser treatment as assessed with high definition optical coherence tomography (OCT). Furthermore changes in retinal function as an effect of treatment will be documented by visual acuity testing using ETDRS charts and microperimetry. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Macular Edema
- What is being tested?
- laser treatment with PASCAL® and laser treatment with conventional laser system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2007to Feb 2014
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age 18 years
- Patients with either retinopathy/maculopathy secondary to diabetes mellitus type I or II with medical indication for segmental or panretinal laser coagulation or with necessity for completion of previous incomplete laser photocoagulation.
- Patients with proliferative diabetic retinopathy requiring panretinal laser treatment (Group 1, 2 and 3)
- Patients with macular edema requiring central focal or grid laser treatment (Group 4).
Who cannot join
- A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Opthalmology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Morphological and Functional Retinal Changes Following Retinal Photocoagulation Using a Semiautomated Patterned Scanning Laser System in Proliferative Retinopathy or Macular Edema Secondary to Diabetes Mellitus or Retinal Vein Occlusion
Imaging of retinal morphological changes with time secondary to laser treatment as assessed with high definition optical coherence tomography (OCT). Furthermore changes in retinal function as an effect of treatment will be documented by visual acuity testing using ETDRS charts and microperimetry. The change in vascular leakage will be assessed by performing fluorescein angiography, flare counts will be performed monthly.
Read the detailed description
Hypertension and diabetes are widespread diseases in our modern society and due to the comfortable, but often unhealthy "western world" lifestyle, the population suffering from its consequences is constantly growing. Vascular pathologies affect the body's entire vascular system subsequently including the circulation and vessels in the eye. For these reasons, after diabetic retinopathy and vein occlusions rank among the most common vascular disorders of the retina, with the highest incidence in a population over the age of 60. As to prevent severe vision loss due to complications induced by these angiopathies, panretinal or segmental laser coagulation is recommended as standard treatment of proliferative retinopathy. So far patients who undergo panretinal coagulation typically receive between 1200 and 1500 lasers spots in two to four sessions over the course of 2 to 4 weeks. Clinical guidelines recommend not exceeding the number of more than 900 applied laser spots per session, due to the development of possible reversible exudative reaction e.g. macular edema. However, the performance of a panretinal photocoagulation is so far a time consuming procedure which is generally painful for the patient. For these reasons new laser systems were developed aiming to solve these obvious drawbacks. Main improvement of these systems is the reduction of the laser burn durations per spot and to enable therefore the rapid application of a large number of spots in a preset pattern. Treatment with reduced pulse duration is associated with less pain for the patient and, compared to several sessions requiring about 30 minutes each when using a conventional laser system, treatment time for a complete panretinal treatment could be significantly reduced. The PASCAL® Laser (Pattern Scan Laser, OptiMedica® Corporation, Santa Clara, CA, USA) is a new commercially available laser system confirming all these requirements.
As the first study part (group I and II) we propose a controlled randomized comparison of single session to conventional multisession panretinal laser treatment, using the Pascal laser system for the single-session protocol and the Pascal laser system or the conventional laser system for the multi-session protocol. Development and regression of a retinal exudative reaction and the eventual onset of transient macular edema will be observed and documented. The morphological changes within the retina induced by laser burns will be imaged mainly using optical coherence tomography techniques. In regard to determine the lowest laser intensity as possible to produce a visible morphologic effect within small retinal areas different laser intensities will be used for photocoagulation of retinal segments to show the effect of a "sub-threshold" and gentle laser burn.
As a second study part (group III), grid pattern laser coagulation will be performed in a conventional way using the Pascal laser system. In a small area of the retinal perifoveal zone showing macular edema, morphologic effects of photocoagulation using titrated low, sub threshold or threshold laser energy will be analyzed using OCT.
- Conditions
- Proliferative Diabetic Retinopathy, Macular Edema
- Being tested
- laser treatment with PASCAL®, laser treatment with conventional laser system
- Keywords
- retinal morphology, laser treatment, pascal laser, HD-OCT
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser treatment with PASCAL®Procedure or surgery
Also called PASCAL® (Pattern Scan Laser, OptiMedica ® Corporation)
panretinal laser treatment - single-session
laser treatment with PASCAL®Procedure or surgery
Also called The PASCAL® (Pattern Scan Laser, OptiMedica ® Corporation)
panretinal laser treatment - multi-session
laser treatment with PASCAL®Procedure or surgery
Also called PASCAL® (Pattern Scan Laser, OptiMedica ® Corporation)
grid / focal laser treatment
laser treatment with conventional laser systemProcedure or surgery
panretinal laser treatment - multi-session according to the conventional protocol, using a conventional laser system
| Study group | Role | What they receive |
|---|---|---|
| group 3 | Active comparator | Group 3: 20 patients with proliferative retinopathy secondary to diabetes mellitus or venous occlusion) with need for panretinal photocoagulation.
Intervention: All patients will receive a multi-session panretinal laser treatment according to the conventional protocol, using a conventional laser system. Receives: Procedure: laser treatment with conventional laser system |
| group 2 | Active comparator | Group 2: 20 patients with proliferative retinopathy secondary to diabetes mellitus or venous occlusion) with need for panretinal photocoagulation randomized into group 2.
Intervention: This group will receive multi-session panretinal laser treatment. The treatment will be performed using Pascal laser system. Receives: Procedure: laser treatment with PASCAL® |
| group 1 | Active comparator | Group 1: 20 patients with proliferative retinopathy secondary to diabetes mellitus or venous occlusion) with need for panretinal photocoagulation randomized into group1.
Intervention: One group will receive a single-session panretinal laser treatment, performed using Pascal laser system. Receives: Procedure: laser treatment with PASCAL® |
| group 4 | Active comparator | Group 4: 20 patients with persistent central or para-central diabetic macular edema receiving focal or grid laser treatment. As the treatment will be performed according to the conventional protocol (single spot), only the Pascal laser system will be used.
Intervention: focal or grid laser treatment Receives: Procedure: laser treatment with PASCAL® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal morphological changes with time secondary to laser treatment as assessed with optical coherence tomography (OCT).
Measured: 2007-2014
Secondary outcomes (1)
changes in retinal function as an effect of treatment, documented by visual acuity testing and microperimetry. The change in vascular leakage will be assessed by performing fluorescein angiography, flare counts will be performed monthly.
Measured: 2007-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startOct 2007
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proliferative Diabetic RetinopathyStudies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharina Kriechbaum, Medical University of Vienna
- Investigators
- Ursula Schmidt-Erfurth, MD, Study chair, Medial University of Vienna, Dept. of OphthalmologyKatharina Kriechbaum, MD, Principal investigator, Medical University of ViennaMatthias Bolz, MD, Principal investigator, Medical University of ViennaSonja Prager, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682240
- Sponsor's protocol ID
- Pascal Study
- Acronym
- pascal
- Status last verified
- Feb 2015
- First submitted
- 20 May 2008
- Last updated
- 16 Feb 2015
- Results posted
- No
Publications
Deak GG, Bolz M, Prager S, Ritter M, Kriechbaum K, Scholda C, Schmidt-Erfurth U; Diabetic Retinopathy Research Group Vienna. Photoreceptor layer regeneration is detectable in the human retina imaged by SD-OCT after laser treatment using subthreshold laser power. Invest Ophthalmol Vis Sci. 2012 Oct 9;53(11):7019-25. doi: 10.1167/iovs.12-10196. Print 2012 Oct.
PubMed 22956609
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Retinal Changes Following Retinal Photocoagulation Using a Semiautomated Patterned Scanning Laser System in Proliferative Retinopathy or Macular Edema Secondary to Diabetes Mellitus or Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT00682240
- Acronym / sponsor ID
- pascal / Pascal Study
- Conditions
- Proliferative Diabetic Retinopathy, Macular Edema
- Keywords
- retinal morphology, laser treatment, pascal laser, HD-OCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 May 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.
Imaging of retinal morphological changes with time secondary to laser treatment as assessed with high definition optical coherence tomography (OCT). Furthermore changes in retinal function as an effect of treatment will be documented by visual acuity testing using ETDRS charts and microperimetry. The change in vascular leakage will be assessed by performing fluorescein angiography, flare counts will be performed monthly.
Detailed description
Hypertension and diabetes are widespread diseases in our modern society and due to the comfortable, but often unhealthy "western world" lifestyle, the population suffering from its consequences is constantly growing. Vascular pathologies affect the body's entire vascular system subsequently including the circulation and vessels in the eye. For these reasons, after diabetic retinopathy and vein occlusions rank among the most common vascular disorders of the retina, with the highest incidence in a population over the age of 60. As to prevent severe vision loss due to complications induced by these angiopathies, panretinal or segmental laser coagulation is recommended as standard treatment of proliferative retinopathy. So far patients who undergo panretinal coagulation typically receive between 1200 and 1500 lasers spots in two to four sessions over the course of 2 to 4 weeks. Clinical guidelines recommend not exceeding the number of more than 900 applied laser spots per session, due to the development of possible reversible exudative reaction e.g. macular edema. However, the performance of a panretinal photocoagulation is so far a time consuming procedure which is generally painful for the patient. For these reasons new laser systems were developed aiming to solve these obvious drawbacks. Main improvement of these systems is the reduction of the laser burn durations per spot and to enable therefore the rapid application of a large number of spots in a preset pattern. Treatment with reduced pulse duration is associated with less pain for the patient and, compared to several sessions requiring about 30 minutes each when using a conventional laser system, treatment time for a complete panretinal treatment could be significantly reduced. The PASCAL® Laser (Pattern Scan Laser, OptiMedica® Corporation, Santa Clara, CA, USA) is a new commercially available laser system confirming all these requirements.
As the first study part (group I and II) we propose a controlled randomized comparison of single session to conventional multisession panretinal laser treatment, using the Pascal laser system for the single-session protocol and the Pascal laser system or the conventional laser system for the multi-session protocol. Development and regression of a retinal exudative reaction and the eventual onset of transient macular edema will be observed and documented. The morphological changes within the retina induced by laser burns will be imaged mainly using optical coherence tomography techniques. In regard to determine the lowest laser intensity as possible to produce a visible morphologic effect within small retinal areas different laser intensities will be used for photocoagulation of retinal segments to show the effect of a "sub-threshold" and gentle laser burn.
As a second study part (group III), grid pattern laser coagulation will be performed in a conventional way using the Pascal laser system. In a small area of the retinal perifoveal zone showing macular edema, morphologic effects of photocoagulation using titrated low, sub threshold or threshold laser energy will be analyzed using OCT.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 3 | Active comparator | Procedure: laser treatment with conventional laser systemGroup 3: 20 patients with proliferative retinopathy secondary to diabetes mellitus or venous occlusion) with need for panretinal photocoagulation. Intervention: All patients will receive a multi-session panretinal laser treatment according to the conventional protocol, using a conventional laser system. |
| group 2 | Active comparator | Procedure: laser treatment with PASCAL®Group 2: 20 patients with proliferative retinopathy secondary to diabetes mellitus or venous occlusion) with need for panretinal photocoagulation randomized into group 2. Intervention: This group will receive multi-session panretinal laser treatment. The treatment will be performed using Pascal laser system. |
| group 1 | Active comparator | Procedure: laser treatment with PASCAL®Group 1: 20 patients with proliferative retinopathy secondary to diabetes mellitus or venous occlusion) with need for panretinal photocoagulation randomized into group1. Intervention: One group will receive a single-session panretinal laser treatment, performed using Pascal laser system. |
| group 4 | Active comparator | Procedure: laser treatment with PASCAL®Group 4: 20 patients with persistent central or para-central diabetic macular edema receiving focal or grid laser treatment. As the treatment will be performed according to the conventional protocol (single spot), only the Pascal laser system will be used. Intervention: focal or grid laser treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Age 18 years
- Patients with either retinopathy/maculopathy secondary to diabetes mellitus type I or II with medical indication for segmental or panretinal laser coagulation or with necessity for completion of previous incomplete laser photocoagulation.
- Patients with proliferative diabetic retinopathy requiring panretinal laser treatment (Group 1, 2 and 3)
- Patients with macular edema requiring central focal or grid laser treatment (Group 4).
Key exclusion criteria (1 listed)
- A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure.
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 |
|---|---|---|
| laser treatment with PASCAL®Also: PASCAL® (Pattern Scan Laser, OptiMedica ® Corporation)panretinal laser treatment - single-session | Procedure or surgery | group 1 |
| laser treatment with PASCAL®Also: The PASCAL® (Pattern Scan Laser, OptiMedica ® Corporation)panretinal laser treatment - multi-session | Procedure or surgery | group 2 |
| laser treatment with PASCAL®Also: PASCAL® (Pattern Scan Laser, OptiMedica ® Corporation)grid / focal laser treatment | Procedure or surgery | group 4 |
| laser treatment with conventional laser systempanretinal laser treatment - multi-session according to the conventional protocol, using a conventional laser system | Procedure or surgery | group 3 |
Primary outcome
Retinal morphological changes with time secondary to laser treatment as assessed with optical coherence tomography (OCT).
Time frame: 2007-2014
1 secondary outcome
changes in retinal function as an effect of treatment, documented by visual acuity testing and microperimetry. The change in vascular leakage will be assessed by performing fluorescein angiography, flare counts will be performed monthly.
Time frame: 2007-2009
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 Feb 2015.
- Derived from this study: PubMed 22956609Deak GG, Bolz M, Prager S, Ritter M, Kriechbaum K, Scholda C, Schmidt-Erfurth U; Diabetic Retinopathy Research Group Vienna. Photoreceptor layer regeneration is detectable in the human retina imaged by SD-OCT after laser treatment using subthreshold laser power. Invest Ophthalmol Vis Sci. 2012 Oct 9;53(11):7019-25. doi: 10.1167/iovs.12-10196. Print 2012 Oct.
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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.
Ursula Schmidt-Erfurth, MD study chair
Medial University of Vienna, Dept. of Ophthalmology
Katharina Kriechbaum, MD principal investigator
Medical University of Vienna
Matthias Bolz, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing laser treatment with PASCAL® and laser treatment with conventional laser system in people with Proliferative Diabetic Retinopathy and Macular Edema, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 1 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 Feb 2015. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Retinal morphological changes with time secondary to laser treatment as assessed with optical coherence tomography (OCT). (time frame: 2007-2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00682240, which also lists 1 linked publication.
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 Feb 2015.