Retinal DiseaseNCT03786146
Changes in Retinal Nerve Fiber Layer Thickness Detected by OCT in Diabetic Retinopathy After Panretinal Photocoagulation
An observational study of Retinal Disease, run by Assiut University.
Trial summary
Panretinal photocoagulation reduces the risk of visual loss by 50% in patients with diabetic retinopathy. It is recognized that laser expansion into the retina may be associated with photoreceptor loss, retinal pigment epithelial hypertrophy and visual field loss. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Retinal Disease
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to Dec 2019
- 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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: The study will be carried out on patients with a clinical diagnosis of proliferative diabetic retinopathy treated by panretinal photocoagulation.
Who may be able to join
- Patients with a clinical diagnosis of proliferative diabetic retinopathy.
- Treated by panretinal photocoagulation.
- Age between 40-70 years old.
Who cannot join
- Patients with densely opaque media (as dense cataract or vitreous hemorrhage).
- Glaucomatous patients.
- Any other associated retinopathy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Changes in Retinal Nerve Fiber Layer Thickness Detected by Optical Coherence Tomography in Diabetic Retinopathy After Panretinal Photocoagulation
Panretinal photocoagulation reduces the risk of visual loss by 50% in patients with diabetic retinopathy. It is recognized that laser expansion into the retina may be associated with photoreceptor loss, retinal pigment epithelial hypertrophy and visual field loss.
Panretinal photocoagulation can cause alteration in retinal vascular permeability therefore, retinal thickness may be increased including retinal nerve fiber layer. On the contrary, it can damage retinal cells including ganglion cells, which may decrease the retinal nerve fiber layer thickness in the latter follow up period.
Peripapillary retinal nerve fiber layer can be measured by optical coherence tomography which is a non-invasive technique for obtaining high resolution cross sectional images of a tissue.
Read the detailed description
Pre laser assessment:
- Assessment of medical and family history
- Refraction and best corrected visual acuity
- Anterior segment examination using binocular slit lamp bi-microscopy.
- Posterior segment examination.
- OCT scan of peripapillary area
Post laser assessment ( at 1,3 and 6 months):
- Refraction and best corrected visual acuity.
- Anterior segment examination using binocular slit lamp bi-microscopy.
- Posterior segment examination.
- OCT scan of peripapillary area.
- Conditions
- Retinal Disease
- Medical subject headings
- Retinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
Measured: 0 (before laser treatment ).
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
Measured: 1 month post laser treatment.
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
Measured: 3 months post laser treatment.
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
Measured: 6 months post laser treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania M. Goda, Assiut University
- Investigators
- rania goda, Principal investigator, researcher in Assiut universityehab wasfi, Study director, Assiut UniversityAli Netag, Study director, Assiut UniversityKamel Abd Elnaser, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786146
- Sponsor's protocol ID
- RNFL in diabetic after PRP
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wagdy F, El Sobky H, Sarhan AE-R, Hafez M. Evaluation of retinal nerve fiber layer thickness in diabetic retinopathy by optical coherence tomography after full scatter panretinal argon laser photocoagulation. J Egypt Ophthalmol Soc [Internet]. 2013 Jul 1;106(3):153-8. Available from: http://www.jeos.eg.net/article.asp?issn=2090-0686
Kim HY, Cho HK. Peripapillary retinal nerve fiber layer thickness change after panretinal photocoagulation in patients with diabetic retinopathy. Korean J Ophthalmol. 2009 Mar;23(1):23-6. doi: 10.3341/kjo.2009.23.1.23. Epub 2009 Mar 9.
PubMed 19337475Kim J, Woo SJ, Ahn J, Park KH, Chung H, Park KH. Long-term temporal changes of peripapillary retinal nerve fiber layer thickness before and after panretinal photocoagulation in severe diabetic retinopathy. Retina. 2012 Nov-Dec;32(10):2052-60. doi: 10.1097/IAE.0b013e3182562000.
PubMed 23099450Paunescu LA, Schuman JS, Price LL, Stark PC, Beaton S, Ishikawa H, Wollstein G, Fujimoto JG. Reproducibility of nerve fiber thickness, macular thickness, and optic nerve head measurements using StratusOCT. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1716-24. doi: 10.1167/iovs.03-0514.
PubMed 15161831Lim MC, Tanimoto SA, Furlani BA, Lum B, Pinto LM, Eliason D, Prata TS, Brandt JD, Morse LS, Park SS, Melo LA Jr. Effect of diabetic retinopathy and panretinal photocoagulation on retinal nerve fiber layer and optic nerve appearance. Arch Ophthalmol. 2009 Jul;127(7):857-62. doi: 10.1001/archophthalmol.2009.135.
PubMed 19597104Muqit MM, Wakely L, Stanga PE, Henson DB, Ghanchi FD. Effects of conventional argon panretinal laser photocoagulation on retinal nerve fibre layer and driving visual fields in diabetic retinopathy. Eye (Lond). 2010 Jul;24(7):1136-42. doi: 10.1038/eye.2009.308. Epub 2009 Dec 18.
PubMed 20019760
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Retinal Nerve Fiber Layer Thickness Detected by Optical Coherence Tomography in Diabetic Retinopathy After Panretinal Photocoagulation
- ClinicalTrials.gov ID
- NCT03786146
- Acronym / sponsor ID
- RNFL in diabetic after PRP
- Conditions
- Retinal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 Dec 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.
Panretinal photocoagulation reduces the risk of visual loss by 50% in patients with diabetic retinopathy. It is recognized that laser expansion into the retina may be associated with photoreceptor loss, retinal pigment epithelial hypertrophy and visual field loss.
Panretinal photocoagulation can cause alteration in retinal vascular permeability therefore, retinal thickness may be increased including retinal nerve fiber layer. On the contrary, it can damage retinal cells including ganglion cells, which may decrease the retinal nerve fiber layer thickness in the latter follow up period.
Peripapillary retinal nerve fiber layer can be measured by optical coherence tomography which is a non-invasive technique for obtaining high resolution cross sectional images of a tissue.
Detailed description
Pre laser assessment:
- Assessment of medical and family history
- Refraction and best corrected visual acuity
- Anterior segment examination using binocular slit lamp bi-microscopy.
- Posterior segment examination.
- OCT scan of peripapillary area
Post laser assessment ( at 1,3 and 6 months):
- Refraction and best corrected visual acuity.
- Anterior segment examination using binocular slit lamp bi-microscopy.
- Posterior segment examination.
- OCT scan of peripapillary area.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will be carried out on patients with a clinical diagnosis of proliferative diabetic retinopathy treated by panretinal photocoagulation.
Key inclusion criteria (3 listed)
- Patients with a clinical diagnosis of proliferative diabetic retinopathy.
- Treated by panretinal photocoagulation.
- Age between 40-70 years old.
Key exclusion criteria (3 listed)
- Patients with densely opaque media (as dense cataract or vitreous hemorrhage).
- Glaucomatous patients.
- Any other associated retinopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
Time frame: 0 (before laser treatment ).
A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
Time frame: 1 month post laser treatment.
A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
Time frame: 3 months post laser treatment.
A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
Time frame: 6 months post laser treatment.
A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- BackgroundWagdy F, El Sobky H, Sarhan AE-R, Hafez M. Evaluation of retinal nerve fiber layer thickness in diabetic retinopathy by optical coherence tomography after full scatter panretinal argon laser photocoagulation. J Egypt Ophthalmol Soc [Internet]. 2013 Jul 1;106(3):153-8. Available from: http://www.jeos.eg.net/article.asp?issn=2090-0686
- Background: PubMed 19337475Kim HY, Cho HK. Peripapillary retinal nerve fiber layer thickness change after panretinal photocoagulation in patients with diabetic retinopathy. Korean J Ophthalmol. 2009 Mar;23(1):23-6. doi: 10.3341/kjo.2009.23.1.23. Epub 2009 Mar 9.
- Background: PubMed 23099450Kim J, Woo SJ, Ahn J, Park KH, Chung H, Park KH. Long-term temporal changes of peripapillary retinal nerve fiber layer thickness before and after panretinal photocoagulation in severe diabetic retinopathy. Retina. 2012 Nov-Dec;32(10):2052-60. doi: 10.1097/IAE.0b013e3182562000.
- Background: PubMed 15161831Paunescu LA, Schuman JS, Price LL, Stark PC, Beaton S, Ishikawa H, Wollstein G, Fujimoto JG. Reproducibility of nerve fiber thickness, macular thickness, and optic nerve head measurements using StratusOCT. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1716-24. doi: 10.1167/iovs.03-0514.
- Background: PubMed 19597104Lim MC, Tanimoto SA, Furlani BA, Lum B, Pinto LM, Eliason D, Prata TS, Brandt JD, Morse LS, Park SS, Melo LA Jr. Effect of diabetic retinopathy and panretinal photocoagulation on retinal nerve fiber layer and optic nerve appearance. Arch Ophthalmol. 2009 Jul;127(7):857-62. doi: 10.1001/archophthalmol.2009.135.
- Background: PubMed 20019760Muqit MM, Wakely L, Stanga PE, Henson DB, Ghanchi FD. Effects of conventional argon panretinal laser photocoagulation on retinal nerve fibre layer and driving visual fields in diabetic retinopathy. Eye (Lond). 2010 Jul;24(7):1136-42. doi: 10.1038/eye.2009.308. Epub 2009 Dec 18.
- Individual participant dataSharing planned: Undecided
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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.
rania goda principal investigator
researcher in Assiut university
ehab wasfi study director
Assiut University
Ali Netag study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease, run by Assiut University.
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 3 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 24 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ehab wasfi, assist prof (00201000373344, ehabinegypt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers. (time frame: 0 (before laser treatment ).). The study lists 4 primary outcomes in all. 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 NCT03786146, which also lists 6 linked publications.
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 24 Dec 2018.