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Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations.
The study will include 20 patients with bilateral cataract (40 eyes). The experimental group will include eyes for which a new injectable mydriatic combination are used to dilate the pupil. The control group will include cases where standard mydriatic eye drops are used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine sulfate and Epinephrine | Experimental | Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist). |
|
| Topical cyclopentolate and phenylephrine | Other | Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine sulfate and epinephrine | Drug | Experimental arm:Combined use of subconjunctival atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral epinephrine 1:100000 ( sympathetic agonist). Control arm :topical mydriatics are used for pupil dilation. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative pupil diameter | Intraoperative pupil diameter measurements of involved eye in mm | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Complications such as subconjunctival hemorrhage or corneal edema [Time Frame: starting from the first postoperative day till one month] | Starting from first postoperative day till one month. |
| Postoperative corneal thickness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ewais | Contact | +01223638543 | waelewais74@gmail.com | |
| Ali | Contact | +01005005707 |
| Name | Affiliation | Role |
|---|---|---|
| Nossair | Dar El Oyoun Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dar El Oyoun Hospital | Recruiting | Cairo | Giza Governorate | 1261 | Egypt |
Identity and names of participant will be hidden. Data related to outcome measures can be shared
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D015878 | Mydriasis |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D011681 | Pupil Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| D004837 | Epinephrine |
| D003519 | Cyclopentolate |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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Randomized clinical study
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Preoperative and postoperative assessment will be done by a masked observer.
|
| Topical cyclopentolate and phenylephrine | Drug | Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used. |
|
|
Measured by specular microscopy in ( mm ) |
| 1 month after surgery |
| Postoperative corneal endothelial density | Measured by specular microscopy in ( cell number/mm2) | 1 month after surgery |
| Postoperative pupil diameter | Postoperative diameter of involved eye in mm | one day, one week and one month after surgery |
| Postoperative visual acuity | Postoperative best corrected distance visual acuity in logmar units. | One day, one week and one month after surgery |
| Postoperative intraocular pressure (IOP) | Postoperative IOP measured in mmHg | One day, one week and one month after surgery |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |