Epiretinal Membranectomy Clinical Trial
| Verified date | August 2014 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Korea Food and Drug Administration (KFDA) |
| Study type | Observational |
Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical instrument renovation, it seems to have been changed the surgical indication. Therefore, we plan to evaluate the changes of binocular visual acuity, aniseikonia in patients with epiretinal membrane.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Idiopathic epiretinal membrane who had impaired vision or metamorphopsia, want to undergo vitrectomy - Age more than 20 years and less than 90 years old Exclusion Criteria: - secondary epiretinal membrane due to retinal surgery, - impaired visual acuity less than 20/40 in the normal eye(Snellen chart) due to severe cataract - glaucoma patients - complication during vitrectomy (ex. Retinal tear, silicone oil injection, …) - other retinal disease except epiretinal membrane - other ocular surgery history within 3 months - intellectual problems or illiterate whom could not obtained informed consent |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Institute of Vision Research, Department of Ophthalmology, Gangnam Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes of Stereopsis tested by TNO test (arc of second) | Stereopsis is normal binocular vision. Its presence or absence is an important indicator of the state of binocularity. The TNO test is graded to provide retinal disparities ranging from 15 to 480 second of arc. | from Initial screening day before surgey to postoperative 6 months | No |
| Primary | Titmus test (arc of second) | from Initial screening day before surgey to postoperative 6 months | No |