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This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.
The rationale behind using Apraclonidine is that it acts on Muller's muscle which is a sympathetic-innervated muscle. As such, this muscle is expected to be spared from the effects of the autoantibodies that attack the postsynaptic portion of the neuromuscular junction in myasthenia gravis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye. Objective measurements of ptosis will be taken before drug administration and at 1, 5, 30, 60 minutes after drug administration in order to analyze any change in ptosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apraclonidine Hcl 0.5% Oph Soln | Drug | Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in palpebral fissure height (PF) | Change in PF measurements | Before administration, at 1, 5, 30, and 60 minutes after administration |
| Change in marginal reflex distance-1 (MRD1) | Change in MRD1 measurements | Before administration, at 1, 5, 30, and 60 minutes after administration |
| Change in marginal reflex distance-2 (MRD2) | Change in MRD2 measurements | Before administration, at 1, 5, 30, and 60 minutes after administration |
| Change in levator function (LF) | Change in LF measurements | Before administration, at 1, 5, 30, and 60 minutes after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnny Salameh, MD | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut Medical Center | Beirut | 1107 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37259693 | Derived | Agha M, Ismail H, Sawaya R, Salameh J. Efficacy of apraclonidine eye drops in treating ptosis secondary to myasthenia gravis: A pilot clinical trial. Muscle Nerve. 2023 Aug;68(2):206-210. doi: 10.1002/mus.27851. Epub 2023 May 31. |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C016986 | apraclonidine |
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| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |