Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.

Conditions
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Cataract, Mydriasis, Adverse Drug Event

Intervention / Treatment
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* Drug: Atropine sulfate and epinephrine
* Drug: Topical cyclopentolate and phenylephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases of bilateral visually significant cataract Exclusion Criteria: Poor pupil dilation(less than 6 mm diameter). History of previous eye surgery or trauma History of use of eye drops affecting pupil size such as pilocarpine. Known drug allergy to cyclopentolate,phenylephrine, atropine sulfate or epinephrine. Pediatric age group (less than 18 years old). Pupil abnormalities, such as anisocoria or neurological disorders. Associated glaucoma, uveitis, corneal, retinal or optic nerve disease. Cases scheduled for phacoemulsification under general anaesthesia (to exclude possible ocular and systemic effects or interactions of anaesthetic agents). Patients with bleeding tendency or on anti-coagulant therapy (because peribulbar and subconjunctival injections are used).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atropine sulfate and Epinephrine<br>Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist). | Drug: Atropine sulfate and epinephrine<br>* 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.<br>* Other names: Atropine (Misr.co), Epinephrine (Misr.co);|
| Other: Topical cyclopentolate and phenylephrine<br>Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine. | Drug: Topical cyclopentolate and phenylephrine<br>* Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.<br>* Other names: Cyclophrine eye drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative pupil diameter | Intraoperative pupil diameter measurements of involved eye in mm | 1 day | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative mydriasis, subconjunctival atropine, intracameral epinephrine, cataract surgery