Diabetic RetinopathyNCT03476967
Effect of Laser Treatment for Diabetic Retinopathy on the Optic Disc Topography
An observational study of Diabetic Retinopathy, run by University of Sao Paulo General Hospital.
Trial summary
This study analyzed diabetic patients without evidence of glaucoma who underwent panretinal photocoagulation to determine the effect on optic disc topographic parameters in non-glaucomatous patients with proliferative diabetic retinopathy (PDR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Panretinal photocoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2017
- How long will I take part?
- 12 Months
- 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 followed in the ophthalmology department of Hospital das Clínicas da FMUSP who have type I or II diabetes mellitus and present severe or very severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy in cases where retinal panphotocoagulation is indicated.
Who may be able to join
- diagnosis of PDR (due to type 1 or 2 diabetes mellitus)
- intraocular pressure < 18 mmHg
- nonglaucomatous optic disc characteristics at fundus examination
- vertical cup-to-disc (C/D) ratio <0.7
- absence of media opacities
Who cannot join
- previous diagnosis of glaucoma
- family history of glaucoma
- neuroophthalmic disease
- uveitis
- retinal artery or vein occlusion
- optic disc neovascularization
Show all 9Show fewer
- diabetic macular edema (DME)
- corneal opacity
- previous laser photocoagulation treatment
About this study
Official title: Effect of Panretinal Photocoagulation on Confocal Laser Scanning Ophthalmoscopy and Stereo Photographic Parameters of the Optic Disc Topography in Diabetic Retinopathy Patients
This study analyzed diabetic patients without evidence of glaucoma who underwent panretinal photocoagulation to determine the effect on optic disc topographic parameters in non-glaucomatous patients with proliferative diabetic retinopathy (PDR).
Read the detailed description
Glaucoma and proliferative diabetic retinopathy (PDR) are two very prevalent diseases that often coexist. Previous literature suggest that panretinal photocoagulation may somehow lead to optic disk cupping. Therefore, evaluation of the optic disc cupping and of possible glaucomatous damage in patients with diabetic retinopathy can be difficult, especially after PRP treatment. The purpose of this study is to determine the long-term effect of PRP on optic disc topographic parameters in non-glaucomatous patients with PDR using Heidelberg retina tomograph (HRT) parameters and stereo photography. The Investigators found that PRP does not cause morphological optic disk changes in diabetic PDR patients after one year of follow-up.
- Conditions
- Diabetic Retinopathy
- Being tested
- Panretinal photocoagulation
- Keywords
- optic disc topography, panretinal photocoagulation, confocal scanning laser ophthalmoscopy, stereoscopic disc photographs, diabetic retinopathy, optic nerve head parameters
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panretinal photocoagulationProcedure or surgery
In cases of proliferative diabetic retinopathy (PDR), panretinal photocoagulation (PRP) is the first-line treatment. Although PRP reduces the risk of severe vision loss, it has been shown that laser energy can cause destruction to all layers of retina including the ganglion cells and the retinal nerve fiber layer (RNFL), and therefore generate visual field defects similar to that observed in glaucomatous damage. In such cases, visual field testing can be less helpful to evaluate glaucomatous damage in PDR patients treated with PRP.
| Study group | Role | What they receive |
|---|---|---|
| Pretreatment x Posttreatment | The group was evaluated through non-invasive complementary examinations before laser therapy and at the 1-year follow-up visit to analyze possible optical disc alterations that may occur after retinal panretinal photocoagulation in patients with proliferative diabetic retinopathy. Receives: Procedure: Panretinal photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cup area
Change in cup area (mm2) measured by Heidelberg retinal tomograph (HRT) before and one year after PRP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study startJan 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Leandro Zacharias, Study director, Division of Ophthalmology, University of São Paulo Medical School, São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476967
- Sponsor's protocol ID
- USaoPauloGH 12423
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Panretinal Photocoagulation on Confocal Laser Scanning Ophthalmoscopy and Stereo Photographic Parameters of the Optic Disc Topography in Diabetic Retinopathy Patients
- ClinicalTrials.gov ID
- NCT03476967
- Acronym / sponsor ID
- USaoPauloGH 12423
- Conditions
- Diabetic Retinopathy
- Keywords
- optic disc topography, panretinal photocoagulation, confocal scanning laser ophthalmoscopy, stereoscopic disc photographs, diabetic retinopathy, optic nerve head parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Mar 2018 (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.
This study analyzed diabetic patients without evidence of glaucoma who underwent panretinal photocoagulation to determine the effect on optic disc topographic parameters in non-glaucomatous patients with proliferative diabetic retinopathy (PDR).
Detailed description
Glaucoma and proliferative diabetic retinopathy (PDR) are two very prevalent diseases that often coexist. Previous literature suggest that panretinal photocoagulation may somehow lead to optic disk cupping. Therefore, evaluation of the optic disc cupping and of possible glaucomatous damage in patients with diabetic retinopathy can be difficult, especially after PRP treatment. The purpose of this study is to determine the long-term effect of PRP on optic disc topographic parameters in non-glaucomatous patients with PDR using Heidelberg retina tomograph (HRT) parameters and stereo photography. The Investigators found that PRP does not cause morphological optic disk changes in diabetic PDR patients after one year of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pretreatment x Posttreatment | – | Procedure: Panretinal photocoagulationThe group was evaluated through non-invasive complementary examinations before laser therapy and at the 1-year follow-up visit to analyze possible optical disc alterations that may occur after retinal panretinal photocoagulation in patients with proliferative diabetic retinopathy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients followed in the ophthalmology department of Hospital das Clínicas da FMUSP who have type I or II diabetes mellitus and present severe or very severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy in cases where retinal panphotocoagulation is indicated.
Key inclusion criteria (5 listed)
- diagnosis of PDR (due to type 1 or 2 diabetes mellitus)
- intraocular pressure < 18 mmHg
- nonglaucomatous optic disc characteristics at fundus examination
- vertical cup-to-disc (C/D) ratio <0.7
- absence of media opacities
Key exclusion criteria (9 listed)
- previous diagnosis of glaucoma
- family history of glaucoma
- neuroophthalmic disease
- uveitis
- retinal artery or vein occlusion
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 |
|---|---|---|
| Panretinal photocoagulationIn cases of proliferative diabetic retinopathy (PDR), panretinal photocoagulation (PRP) is the first-line treatment. Although PRP reduces the risk of severe vision loss, it has been shown that laser energy can cause destruction to all layers of retina including the ganglion cells and the retinal nerve fiber layer (RNFL), and therefore generate visual field defects similar to that observed in glaucomatous damage. In such cases, visual field testing can be less helpful to evaluate glaucomatous damage in PDR patients treated with PRP. | Procedure or surgery | Pretreatment x Posttreatment |
Primary outcome
Cup area
Time frame: 12 months
Change in cup area (mm2) measured by Heidelberg retinal tomograph (HRT) before and one year after PRP
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 26 Mar 2018.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Diabetic Retinopathy
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
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.
Leandro Zacharias study director
Division of Ophthalmology, University of São Paulo Medical School, São Paulo, Brazil
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by University of Sao Paulo General Hospital.
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 9 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 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Cup area (time frame: 12 months). 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 26 Mar 2018.