Adverse Drug Event, Cataract, Mydriasis
Conditions
Keywords
intraoperative mydriasis, subconjunctival atropine, intracameral epinephrine, cataract surgery
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.
Interventions
DRUGAtropine sulfate and epinephrine
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.
DRUGTopical cyclopentolate and phenylephrine
Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.
Sponsors
Dar El Oyoun Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Preoperative and postoperative assessment will be done by a masked observer.
Intervention model description
Randomized clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative pupil diameter | 1 day | Intraoperative pupil diameter measurements of involved eye in mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative corneal thickness | 1 month after surgery | Measured by specular microscopy in ( mm ) |
| Postoperative corneal endothelial density | 1 month after surgery | Measured by specular microscopy in ( cell number/mm2) |
| Postoperative complications | Starting from first postoperative day till one month. | Complications such as subconjunctival hemorrhage or corneal edema \[Time Frame: starting from the first postoperative day till one month\] |
| Postoperative visual acuity | One day, one week and one month after surgery | Postoperative best corrected distance visual acuity in logmar units. |
| Postoperative intraocular pressure (IOP) | One day, one week and one month after surgery | Postoperative IOP measured in mmHg |
| Postoperative pupil diameter | one day, one week and one month after surgery | Postoperative diameter of involved eye in mm |
Countries
Egypt
Contacts
Primary ContactEwais
Backup ContactAli
Outcome results
None listed