Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez | OTHER |
Not provided
Not provided
Not provided
Not provided
Amblyopia, or lazy eye, is best defined by the American Academy of Ophthalmology as a unilateral or bilateral reduction of the best corrected visual acuity that occurs in the setting of an otherwise normal eye, or a structural abnormality involving the eye or visual pathway with reduction in visual acuity that cannot be attributed only to the effect of the structural abnormality. Which causes an abnormal visual experience early in life, with consequences such as deficiencies in the ability to perceive contrast and/or movement, visual acuity, accommodation and stereopsis. The treatment of choice consists in patching of the fellow eye 2 hours per day. The disadvantage of this treatment modality is that patients end up not complying and when treatment is interrupted, lazy eye reappears. Amblyopia was thought to be a monocular disease, now a days there are reports of cortical visual paths changes in both eyes (the fellow and amblyopia eye), believing that it might be a monocular consequence of a binocular disease. Following that statement new treatment studies have arisen, stimulating both eyes not only to improve visual acuity in the lazy eye, but to restore binocular function as well. These treatments use videogames in celular phones, computers, or tablets where the fellow eye is exposed to reduced contrast and the lazy eye is exposed to full-contrast. Although the evidence is promising, more studies are needed to establish effectivity and security of this treatment modality.
The objective of this study is to determine if the binocular visual therapy with red-green glasses and the use of electronic devices is effective for amblyopia treatment in children.
Participants will be randomly assigned to one of three treatment modalities: Group A: eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc) Group B: an eye patch on the fellow eye and a electronic tablet Group C: red/green glasses and a electronic tablet
Treatment will be done buy the three groups daily during 2 consecutive hours, and will be completed for four months. Children will then suspend the therapy for 2 months, and will be reevaluated to determine lazy eye relapses . All groups will be compared to see which patients achieved greater improvement on visual acuity and depth perception.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patch | Active Comparator | Eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc) |
|
| Electronic Devices | Experimental | Eye patch on the fellow eye and a electronic tablet |
|
| Red/Green Glasses | Experimental | Red/green glasses and a electronic tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red/green glasses | Device | The use of red/green glasses and electronic devices for two hours a day during 4 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity of the amblyopic eye | Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis. | Basal |
| Best corrected visual acuity of the amblyopic eye | Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis. | One month of treatment |
| Best corrected visual acuity of the amblyopic eye | Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis. | Two months of treatment |
| Best corrected visual acuity of the amblyopic eye | Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis. | Three months of treatment |
| Best corrected visual acuity of the amblyopic eye | Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis. | Four months of treatment |
| Best corrected visual acuity of the amblyopic eye two months after treatment suspension to determine lazy eye relapses | Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis. | Two months after treatment suspension. |
| Measure | Description | Time Frame |
|---|---|---|
| Stereopsis | Stereopsis measurement by titmus test | Basal |
| Stereopsis | Stereopsis measurement by titmus test | One month of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marissa L. Fernandez-de Luna, MD | Contact | +528183469259 | dra.fernandezdeluna@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marissa L. Fernandez-de Luna, MD | Universidad Autonoma de Nuevo Leon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26263202 | Background | Tailor V, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. Cochrane Database Syst Rev. 2015 Aug 11;2015(8):CD011347. doi: 10.1002/14651858.CD011347.pub2. | |
| 27832248 | Background | Kelly KR, Jost RM, Dao L, Beauchamp CL, Leffler JN, Birch EE. Binocular iPad Game vs Patching for Treatment of Amblyopia in Children: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1402-1408. doi: 10.1001/jamaophthalmol.2016.4224. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Neither the patient or the care provider will be aware of the treatment modality group the patient is in. In order to achieve that, patients in different modality groups will be evaluated in different days preventing information of group modality gossip between the patients parents.
| Electronic Tablet | Device | The use of eye patch on the fellow eye and electronic tablet for 2 hours a day during 4 months. |
|
| Eye patch | Device | The use of eye patch on the fellow eye and near vision activities for 2 hours a day during 4 months. |
|
| Stereopsis | Stereopsis measurement by titmus test | Two months of treatment |
| Stereopsis | Stereopsis measurement by titmus test | Three months of treatment |
| Stereopsis | Stereopsis measurement by titmus test | Four months of treatment |
| Stereopsis two months after treatment suspension to determine lazy eye relapses | Stereopsis measurement by titmus test | Two months after treatment suspension. |
| 29905115 | Background | Hunter D. Amblyopia: The clinician's view. Vis Neurosci. 2018 Jan;35:E011. doi: 10.1017/S0952523817000189. No abstract available. |
| 18513466 | Background | Carlton J, Karnon J, Czoski-Murray C, Smith KJ, Marr J. The clinical effectiveness and cost-effectiveness of screening programmes for amblyopia and strabismus in children up to the age of 4-5 years: a systematic review and economic evaluation. Health Technol Assess. 2008 Jun;12(25):iii, xi-194. doi: 10.3310/hta12250. |
| 17325157 | Background | Grant S, Melmoth DR, Morgan MJ, Finlay AL. Prehension deficits in amblyopia. Invest Ophthalmol Vis Sci. 2007 Mar;48(3):1139-48. doi: 10.1167/iovs.06-0976. |
| 21870915 | Background | Grant S, Moseley MJ. Amblyopia and real-world visuomotor tasks. Strabismus. 2011 Sep;19(3):119-28. doi: 10.3109/09273972.2011.600423. |
| 16540485 | Background | Hrisos S, Clarke MP, Kelly T, Henderson J, Wright CM. Unilateral visual impairment and neurodevelopmental performance in preschool children. Br J Ophthalmol. 2006 Jul;90(7):836-8. doi: 10.1136/bjo.2006.090910. Epub 2006 Mar 15. |
| 21540479 | Background | Niechwiej-Szwedo E, Goltz HC, Chandrakumar M, Hirji Z, Wong AM. Effects of anisometropic amblyopia on visuomotor behavior, III: Temporal eye-hand coordination during reaching. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5853-61. doi: 10.1167/iovs.11-7314. |
| 19933184 | Background | O'Connor AR, Birch EE, Anderson S, Draper H; FSOS Research Group. The functional significance of stereopsis. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):2019-23. doi: 10.1167/iovs.09-4434. Epub 2009 Nov 20. |
| 16520328 | Background | Rahi JS, Cumberland PM, Peckham CS. Does amblyopia affect educational, health, and social outcomes? Findings from 1958 British birth cohort. BMJ. 2006 Apr 8;332(7545):820-5. doi: 10.1136/bmj.38751.597963.AE. Epub 2006 Mar 6. |
| 18235004 | Background | Webber AL, Wood JM, Gole GA, Brown B. The effect of amblyopia on fine motor skills in children. Invest Ophthalmol Vis Sci. 2008 Feb;49(2):594-603. doi: 10.1167/iovs.07-0869. |
| 27756405 | Background | Guo CX, Babu RJ, Black JM, Bobier WR, Lam CS, Dai S, Gao TY, Hess RF, Jenkins M, Jiang Y, Kowal L, Parag V, South J, Staffieri SE, Walker N, Wadham A, Thompson B; BRAVO study team. Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial. Trials. 2016 Oct 18;17(1):504. doi: 10.1186/s13063-016-1635-3. |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |