Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.
Overview
- Phase
- Phase 4
- Intervention
- Atropine sulfate and epinephrine
- Conditions
- Cataract
- Sponsor
- Dar El Oyoun Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Intraoperative pupil diameter
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Dr. Ashraf Nossair, MD
Associate Professor of Ophthalmology, Cairo University
Dar El Oyoun Hospital
Eligibility Criteria
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).
Arms & Interventions
Atropine sulfate and Epinephrine
Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist).
Intervention: Atropine sulfate and epinephrine
Topical cyclopentolate and phenylephrine
Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.
Intervention: Topical cyclopentolate and phenylephrine
Outcomes
Primary Outcomes
Intraoperative pupil diameter
Time Frame: 1 day
Intraoperative pupil diameter measurements of involved eye in mm
Secondary Outcomes
- Postoperative complications(Starting from first postoperative day till one month.)
- Postoperative corneal thickness(1 month after surgery)
- Postoperative corneal endothelial density(1 month after surgery)
- Postoperative pupil diameter(one day, one week and one month after surgery)
- Postoperative visual acuity(One day, one week and one month after surgery)
- Postoperative intraocular pressure (IOP)(One day, one week and one month after surgery)