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| Name | Class |
|---|---|
| The Retina Clinic - London Ophthalmic Institute | UNKNOWN |
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The purpose of this study is to measure how the quality of life, the structure of eye, and vision change after treatment for the opacities in the gel (vitreous) that fills the center of eye which cause vision disturbances commonly called "floaters".
In this study the vitreous floaters are treated using a Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser. The FDA has approved the use of this laser to treat membranes in the eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy | Device | Nd:YAG laser treatment(s) for Vision Degrading Myodesopsia (clinically significant vitreous floaters) in eyes with vitreous opacities due to myopic vitreopathy and posterior vitreous detachment (PVD). |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of vitreous structure by quantitative ultrasonography | baseline, 3 months, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of visual function using contrast sensitivity | baseline, 3 months, 6 months, 12 months | |
| Evaluation of quality of life using Visual Function Questionnaire (VFQ-25) | Individual scores (NEI VFQ 25 score) are recoded and transformed on a scale from 0 to 100, where 100 represents the best possible performance and 0 represents the worst |
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Inclusion Criteria:
Only one eye per patient will be included in this study
Able and willing to give informed consent
Age ≥18 years
Suffering from symptomatic vitreous floaters
Floaters arising from either/both:
Floaters meeting the following characteristics:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Jerry Sebag, MD, FACS, FRCOphth, FARVO | Contact | 714-901-7777 | JSebag@vmrinstitute.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VMR Institute for Vitreous Macula Retina | Recruiting | Huntington Beach | California | 92647 | United States |
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| ID | Term |
|---|---|
| D020255 | Vitreous Detachment |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| baseline, 3 months, 6 months, 12 months |
| Evaluation of quality of life using Vitreous Floater Functional Questionnaire (VFFQ) | Individual scores (VFFQ score) are recoded and transformed on a scale from 0 to 100, where 100 represents the best possible performance and 0 represents the worst | baseline, 3 months, 6 months, 12 months |
| Evaluation of Visual Acuity (ETDRS LogMAR) | baseline, 3 months, 6 months, 12 months |
| Evaluation of Near Visual Acuity | baseline, 3 months, 6 months, 12 months |
| Evaluation of retinal electrical activity changes in response to light stimuli (Photopic Negative Response amplitude) using Electroretinography (ERG) | baseline, 3 months, 6 months, 12 months |
| Visual evaluation of retinal structure changes in sagittal mode using optical coherence tomography (OCT) centered on the fovea | baseline, 3 months, 6 months, 12 months |
| Evaluation of central visual field changes (median light sensitivity) using microperimetry | Scale 0-36dB (0 worst condition; 36dB the best condition) | baseline, 3 months, 6 months, 12 months |