Macular Holes Clinical Trial
Official title:
Asymmetric Elongation of Foveal Tissue After Macular Hole Surgery and Its Impact on Metamorphopsia
Verified date | November 2011 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
In our experience, elongation of foveal tissue after macular hole surgery which was
undetectable by conventional time-domain optical coherence tomography was often observed on
spectral-domain optical coherence tomography images. Elongation of tissues inevitably
induces some degree of disorganization of tissue microstructure.
The purpose of the present study was to evaluate elongation profile of foveal tissue after
macular hole surgery and to investigate its impact on visual acuity and metamorphopsia.
Status | Completed |
Enrollment | 31 |
Est. completion date | October 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients who were diagnosed with idiopathic macular hole Exclusion Criteria: - traumatic macular hole - evidence of ocular inflammation, diabetic retinopathy, hypertensive retinopathy, and retinal vasculitis, media opacity that would influence visual acuity or preclude acquisition of clear spectral domain optical coherence tomography images - presence of cataract judged to affect visual function, -6.0 diopters or more of spherical equivalent, prominent staphyloma - history of intraocular surgery other than uncomplicated cataract surgery, other ocular diseases that may influence the macular microstructure or visual function - patients with indistinct intraretinal structure on spectral domain optical coherence tomography images |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the inter-outer plexiform layer distance | the spectral domain optical coherence tomography scannings were performed at first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery. The inter-outer plexiform layer distance was measured based on optical coherence tomography images at defined time points | first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery | No |
Primary | Changes in best-corrected visual acuity | Best-corrected visual acuity was measured using early treatment diabetic retinopathy study chart at defined time points | first postoperative visit, 2 months, and 6 months after macular hole surgery | No |
Primary | Changes in degree of metamorphopsia | The degree of metamorphopsia was measured using Metamorphopsia-chart at defined time points | first postoperative visit, 2 months, and 6 months after macular hole surgery | No |
Primary | Degree of percent asymmetric elongation on the same plane | The horizontal percent asymmetry was calculated as (nasal distance - temporal distance)/(nasal distance + temporal distance). The vertical percent asymmetry was also calculated as (superior distance - inferior distance)/ (superior distance + inferior distance. | at 6 months postoperative | No |
Primary | Degree of horizontal-vertical percent asymmetry | The percent asymmetry was calculated as (horizontal inter-outer plexiform layer distance - vertical inter-outer plexiform layer distance)/(horizontal inter-outer plexiform layer distance + vertical inter-outer plexiform layer distance). | at 6 months postoperative | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
Completed |
NCT04535622 -
Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery
|
N/A | |
Completed |
NCT03572725 -
Air Tamponade and Non-supine Positioning in Macular Hole Surgery.
|
N/A | |
Completed |
NCT03646695 -
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
|
N/A | |
Completed |
NCT06323902 -
Autologous Platelet-rich Plasma as a Treatment for Macular Holes
|
||
Completed |
NCT01974310 -
Postoperative Positioning After Surgery for Macular Holes
|
N/A | |
Completed |
NCT00537992 -
Blue-Blocking IOLs in Combined Surgery
|
N/A | |
Completed |
NCT05171621 -
Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
|
||
Recruiting |
NCT06000111 -
Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
|
N/A | |
Recruiting |
NCT04135638 -
Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
|
N/A | |
Completed |
NCT03525899 -
Macular Hole After Diabetic Vitrectomy
|
||
Completed |
NCT03917602 -
Human Amniotic Membrane Plug for Large Macular Holes
|
N/A | |
Completed |
NCT04527848 -
Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
|
Phase 4 | |
Recruiting |
NCT04116892 -
Comparative Analysis of Large Macular Hole Surgeries
|
N/A | |
Completed |
NCT01229657 -
Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes
|
N/A | |
Completed |
NCT01306487 -
Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery
|
N/A | |
Completed |
NCT01381965 -
Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
|
N/A | |
Completed |
NCT03174639 -
High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps
|
N/A | |
Recruiting |
NCT05083650 -
Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis
|
N/A | |
Active, not recruiting |
NCT03437759 -
MSC-Exos Promote Healing of MHs
|
Early Phase 1 |