Correlation Between the Visual Acuity & the OCT Pattern of Macular Edema Secondary to RVO

Retinal Vein Occlusion Clinical Trial

Official title:

Correlation Between the Visual Acuity and the OCT Pattern of Macular Edema Secondary to Retinal Vein Occlusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03489915
• Other study ID #: cbtvaatoctpomestrvo
• Status: Not yet recruiting
• First received: March 23, 2018
• Last updated: April 4, 2018
• Start date: May 1, 2018
• Est. completion date: May 2020

Study information

• Verified date: April 2018
• Source: Assiut University
• Contact: Samir Y Saleh, professor
• Phone: 00201003304320
• Email: samir.abouelail[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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 ??

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with macular edema related to vein occlusion .

• Patient's Age above 18 years old .

• Patients able to sit on OCT device .

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

Device:
• OCT
Assessment of macular edema secondary to retinal vein occlusion usin optical coherence tomography and its correlation with visual acuity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Gupta 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. — View Citation

Hayreh 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. — View Citation

Hayreh SS. Classification of central retinal vein occlusion. Ophthalmology. 1983 May;90(5):458-74. — View Citation

Hayreh SS. Retinal vein occlusion. Indian J Ophthalmol. 1994 Sep;42(3):109-32. Review. — View Citation

Moschos 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. — View Citation

Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. Erratum in: Arch Ophthalmol 1997 Oct;115(10):1275. — View Citation

Williamson TH. Central retinal vein occlusion: what's the story? Br J Ophthalmol. 1997 Aug;81(8):698-704. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular edema assessment	Macular edema assessed by OCT in microns	5 minutes
Primary	Visual acuity assessment	Visual acuity assessment through Landolt chart	5 minutes
Secondary	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	5 minutes