A Phase 4 interventional study of Atropine sulfate and epinephrine and Topical cyclopentolate and phenylephrine in Cataract, Mydriasis and Adverse Drug Event, sponsored by Dar El Oyoun Hospital. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Dar El Oyoun Hospital · Phase 4, Interventional, and Other
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 40 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Dar El Oyoun Hospital is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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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
Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.
Drug: Topical cyclopentolate and phenylephrine
Drug pages: Atropine · 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.
Also known as: Atropine (Misr.co), Epinephrine (Misr.co)
Drug pages: Cyclopentolate · Phenylephrine
Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.
Also known as: Cyclophrine eye drops
Intraoperative pupil diameter
Intraoperative pupil diameter measurements of involved eye in mm
Time frame: 1 day
Postoperative complications
Complications such as subconjunctival hemorrhage or corneal edema \[Time Frame: starting from the first postoperative day till one month\]
Time frame: Starting from first postoperative day till one month.
Postoperative corneal thickness
Measured by specular microscopy in ( mm )
Time frame: 1 month after surgery
Postoperative corneal endothelial density
Measured by specular microscopy in ( cell number/mm2)
Time frame: 1 month after surgery
Postoperative pupil diameter
Postoperative diameter of involved eye in mm
Time frame: one day, one week and one month after surgery
Postoperative visual acuity
Postoperative best corrected distance visual acuity in logmar units.
Time frame: One day, one week and one month after surgery
Postoperative intraocular pressure (IOP)
Postoperative IOP measured in mmHg
Time frame: One day, one week and one month after surgery
Plan to share: Undecided — Identity and names of participant will be hidden. Data related to outcome measures can be shared
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Atropine · Epinephrine
Dar El Oyoun Hospital