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The study aims at reversing pupillary dilatation. and cycloplegia in children undergoing cycloplegic refraction for eyeglasses prescription and ocular examination. This will be achieved using pilocarpine , phentolamine or a combination. This may help decrease the glare and improve near vision early to decrease unwanted effects of cycloplegic drops.
To compare the efficacy of pilocarpine 0.1%, phentolamine 0.75%, and combined therapy in reversing cyclopentolate-induced cycloplegia/mydriasis in pediatric patients using a within-subject paired-eye design (treated vs. untreated eye).
Interventions
Cycloplegia Induction:
Both eyes receive cyclopentolate 1% (2 drops, 5 minutes apart). Then cycloplegic effect confirmed at 30 minutes (accommodation ≤2 D, pupil ≥6 mm).
Reversal Agents (administered at 30 minutes post-cyclopentolate):
Pilocarpine group: Pilocarpine 0.1% (1 drop) in the study eye; placebo in the control eye.
Phentolamine group: Phentolamine 0.75% (1 drop) in the study eye; placebo in the control eye.
Combination: Pilocarpine 0.1% + phentolamine 0.75% (1 drop each) in the study eye; placebo in the control eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilocarpine group | Experimental | Children will receive pilocarpine drops in one eye and placebo in the other |
|
| Phentolamine group | Active Comparator | Children will receive phentolamine eye drop in one eye and placebo in the other |
|
| Combined | Experimental | Children will receive a combination of pilocarpine and placebo in one eye and placebo in the other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of phentolamine eye drops to reverse cycloplegia | Drug | Use of phentolamine 0.75% eye drops to reverse cycloplegia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of pupillary dilatation | Hourly for four hours after administration of the drug |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of accommodation after instillation of the drop | Hourly for four hours after administration of the drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed AlNagdy | Contact | +201096710982 | imanatta@mans.edu.eg |
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| Pilocarpine 0.1% | Drug | Use of pilocarpine 0.1% to reverse cycloplegia |
|
| Combination of pilocarpine 0.1% and phentolamine 0.75% | Drug | Combination of pilocarpine 0.1% and phentolamine 0.75% |
|
| ID | Term |
|---|---|
| D015877 | Miosis |
| ID | Term |
|---|---|
| D011681 | Pupil Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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