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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03489915
Collaborator
(none)
30
24

Study Details

Study Description

Brief 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 ??

Condition or Disease Intervention/Treatment Phase
  • Device: OCT

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

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Correlation Between the Visual Acuity and the OCT Pattern of Macular Edema Secondary to Retinal Vein Occlusion
Anticipated Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Mar 30, 2020
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients with macular edema due to RVO

assessment of visual acuity using Landolt chart and follow up of macular edema using OCT

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

Outcome Measures

Primary Outcome Measures

  1. Macular edema assessment [5 minutes]

    Macular edema assessed by OCT in microns

  2. Visual acuity assessment [5 minutes]

    Visual acuity assessment through Landolt chart

Secondary Outcome Measures

  1. Causes of non improvement of visual acuity in patients with resolving macular edema [5 minutes]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Abdelsalam a Mohamed, ass. prof., Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ali Omar Mohamed Ali, Resident, Assiut University
ClinicalTrials.gov Identifier:
NCT03489915
Other Study ID Numbers:
  • cbtvaatoctpomestrvo
First Posted:
Apr 6, 2018
Last Update Posted:
Apr 6, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2018