Retinal Vein OcclusionNCT03489915
Correlation Between the Visual Acuity & the OCT Pattern of Macular Edema Secondary to RVO
An observational study of Retinal Vein Occlusion, run by Assiut University.
Trial summary
Correlation between changes observed in OCT and VA in patients with retinal vein occlusion whether the patient's VA improves when macular edema improves in OCT or not ?? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- OCT
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: in patients developing retinal vein occlusion for following up their changes in OCT \& VA
Who may be able to join
- Patients with macular edema related to vein occlusion .
- Patient's Age above 18 years old .
- Patients able to sit on OCT device .
Who cannot join
- Significant cataract .
- Media opacities as vitreous haemorrhage .
- patients with macular edema related to CRVO treated by laser photocoagulation .
- patients with glaucoma .
- Patients with chronic uveitis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between the Visual Acuity and the OCT Pattern of Macular Edema Secondary to Retinal Vein Occlusion
Correlation between changes observed in OCT and VA in patients with retinal vein occlusion whether the patient's VA improves when macular edema improves in OCT or not ??
Read the detailed description
Central retinal vein occlusion (CRVO) is a common retinal vascular disorder. Clinically, CRVO presents with variable visual loss; fundus may show retinal hemorrhages, dilated tortuous retinal veins, cotton-wool spots, macular edIn view of the devastating complications associated with the severe form of CRVO, number of classifications were described. All of classifications take into account the area of retinal capillary nonperfusion and development of neovascular complications.
CRVO can be divided into 2 clinical types, ischemic and nonischemic. In addition, a number of patients may have an intermediate presentation with variable clinical course. On initial presentation, it may be difficult to classify a given patient, since CRVO may change with time.
A number of clinical and ancillary investigative factors are taken into account for classifying CRVO:
Nonischemic CRVO is milder form of disease. It may present with good vision, few retinal hemorrhages and cotton-wool spots, no relative afferent pupillary defect, and good perfusion to the retina. Nonischemic CRVO may resolve fully with good visual outcome or may progress to the ischemic type.
Ischemic CRVO is the severe form of the disease. CRVO may present initially as the ischemic type, or it may progress from nonischemic. Usually, ischemic CRVO presents with severe visual loss, extensive retinal hemorrhages and cotton-wool spots, presence of relative afferent pupillary defect, poor perfusion to retina, and presence of severe electroretinographic changes. In addition, patients may end up with neovascular glaucoma and a painful blind eye.
- Conditions
- Retinal Vein Occlusion
- Being tested
- OCT
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
Assessment of macular edema secondary to retinal vein occlusion usin optical coherence tomography and its correlation with visual acuity
| Study group | Role | What they receive |
|---|---|---|
| Patients with macular edema due to RVO | assessment of visual acuity using Landolt chart and follow up of macular edema using OCT Receives: Device: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular edema assessment
Macular edema assessed by OCT in microns
Measured: 5 minutes
Visual acuity assessment
Visual acuity assessment through Landolt chart
Measured: 5 minutes
Secondary outcomes (1)
Causes of non improvement of visual acuity in patients with resolving macular edema
To detect causes of visual non improvement with visual acuity measured through Landolt chart in patients with resolving macular edema measured by OCT device in microns
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion30 Mar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Retinal Vein OcclusionStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Omar Mohamed Ali, Assiut University
- Investigators
- Abdelsalam a Mohamed, ass. prof., Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489915
- Sponsor's protocol ID
- cbtvaatoctpomestrvo
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2018
- Last updated
- 6 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. doi: 10.1001/archopht.1997.01100150488006.
PubMed 9109757Hayreh SS. Classification of central retinal vein occlusion. Ophthalmology. 1983 May;90(5):458-74. doi: 10.1016/s0161-6420(83)34530-9.
PubMed 6877778Hayreh SS. Retinal vein occlusion. Indian J Ophthalmol. 1994 Sep;42(3):109-32.
PubMed 7829175Williamson TH. Central retinal vein occlusion: what's the story? Br J Ophthalmol. 1997 Aug;81(8):698-704. doi: 10.1136/bjo.81.8.698. No abstract available.
PubMed 9349161Hayreh SS, Zimmerman MB, Podhajsky P. Incidence of various types of retinal vein occlusion and their recurrence and demographic characteristics. Am J Ophthalmol. 1994 Apr 15;117(4):429-41. doi: 10.1016/s0002-9394(14)70001-7.
PubMed 8154523Moschos MM, Moschos M. Intraocular bevacizumab for macular edema due to CRVO. A multifocal-ERG and OCT study. Doc Ophthalmol. 2008 Mar;116(2):147-52. doi: 10.1007/s10633-007-9110-9. Epub 2008 Jan 10.
PubMed 18189152Gupta B, Grewal J, Adewoyin T, Pelosini L, Williamson TH. Diurnal variation of macular oedema in CRVO: prospective study. Graefes Arch Clin Exp Ophthalmol. 2009 May;247(5):593-6. doi: 10.1007/s00417-008-1011-4. Epub 2008 Dec 4.
PubMed 19052771
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Visual Acuity and the OCT Pattern of Macular Edema Secondary to Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT03489915
- Acronym / sponsor ID
- cbtvaatoctpomestrvo
- Conditions
- Retinal Vein Occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 6 Apr 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.
Correlation between changes observed in OCT and VA in patients with retinal vein occlusion whether the patient's VA improves when macular edema improves in OCT or not ??
Detailed description
Central retinal vein occlusion (CRVO) is a common retinal vascular disorder. Clinically, CRVO presents with variable visual loss; fundus may show retinal hemorrhages, dilated tortuous retinal veins, cotton-wool spots, macular edIn view of the devastating complications associated with the severe form of CRVO, number of classifications were described. All of classifications take into account the area of retinal capillary nonperfusion and development of neovascular complications.
CRVO can be divided into 2 clinical types, ischemic and nonischemic. In addition, a number of patients may have an intermediate presentation with variable clinical course. On initial presentation, it may be difficult to classify a given patient, since CRVO may change with time.
A number of clinical and ancillary investigative factors are taken into account for classifying CRVO:
Nonischemic CRVO is milder form of disease. It may present with good vision, few retinal hemorrhages and cotton-wool spots, no relative afferent pupillary defect, and good perfusion to the retina. Nonischemic CRVO may resolve fully with good visual outcome or may progress to the ischemic type.
Ischemic CRVO is the severe form of the disease. CRVO may present initially as the ischemic type, or it may progress from nonischemic. Usually, ischemic CRVO presents with severe visual loss, extensive retinal hemorrhages and cotton-wool spots, presence of relative afferent pupillary defect, poor perfusion to retina, and presence of severe electroretinographic changes. In addition, patients may end up with neovascular glaucoma and a painful blind eye.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with macular edema due to RVO | – | Device: OCTassessment of visual acuity using Landolt chart and follow up of macular edema using OCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in patients developing retinal vein occlusion for following up their changes in OCT \& VA
Key inclusion criteria (3 listed)
- Patients with macular edema related to vein occlusion .
- Patient's Age above 18 years old .
- Patients able to sit on OCT device .
Key exclusion criteria (5 listed)
- Significant cataract .
- Media opacities as vitreous haemorrhage .
- patients with macular edema related to CRVO treated by laser photocoagulation .
- patients with glaucoma .
- Patients with chronic uveitis.
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 |
|---|---|---|
| OCTAssessment of macular edema secondary to retinal vein occlusion usin optical coherence tomography and its correlation with visual acuity | Device | Patients with macular edema due to RVO |
Primary outcome
Macular edema assessment
Time frame: 5 minutes
Macular edema assessed by OCT in microns
Visual acuity assessment
Time frame: 5 minutes
Visual acuity assessment through Landolt chart
1 secondary outcome
Causes of non improvement of visual acuity in patients with resolving macular edema
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Background: PubMed 9109757Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. doi: 10.1001/archopht.1997.01100150488006.
- Background: PubMed 6877778Hayreh SS. Classification of central retinal vein occlusion. Ophthalmology. 1983 May;90(5):458-74. doi: 10.1016/s0161-6420(83)34530-9.
- Background: PubMed 7829175Hayreh SS. Retinal vein occlusion. Indian J Ophthalmol. 1994 Sep;42(3):109-32.
- Background: PubMed 9349161Williamson TH. Central retinal vein occlusion: what's the story? Br J Ophthalmol. 1997 Aug;81(8):698-704. doi: 10.1136/bjo.81.8.698. No abstract available.
- Results publication: PubMed 8154523Hayreh SS, Zimmerman MB, Podhajsky P. Incidence of various types of retinal vein occlusion and their recurrence and demographic characteristics. Am J Ophthalmol. 1994 Apr 15;117(4):429-41. doi: 10.1016/s0002-9394(14)70001-7.
- Results publication: PubMed 18189152Moschos MM, Moschos M. Intraocular bevacizumab for macular edema due to CRVO. A multifocal-ERG and OCT study. Doc Ophthalmol. 2008 Mar;116(2):147-52. doi: 10.1007/s10633-007-9110-9. Epub 2008 Jan 10.
- Results publication: PubMed 19052771Gupta B, Grewal J, Adewoyin T, Pelosini L, Williamson TH. Diurnal variation of macular oedema in CRVO: prospective study. Graefes Arch Clin Exp Ophthalmol. 2009 May;247(5):593-6. doi: 10.1007/s00417-008-1011-4. Epub 2008 Dec 4.
- 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.
Abdelsalam a Mohamed, ass. prof. study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Vein Occlusion, 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 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 6 Apr 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 Samir Y Saleh, professor (00201003304320, samir.abouelail@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular edema assessment (time frame: 5 minutes). 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?
On the ClinicalTrials.gov record for NCT03489915, which also lists 7 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 6 Apr 2018.