Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
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|ClinicalTrials.gov Identifier: NCT03638726|
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cataract Mydriasis Adverse Drug Event||Drug: Atropine sulfate and epinephrine Drug: Topical cyclopentolate and phenylephrine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized clinical study|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Preoperative and postoperative assessment will be done by a masked observer.|
|Official Title:||Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.|
|Actual Study Start Date :||September 28, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: 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).
Drug: Atropine 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.
Other Name: Atropine (Misr.co), Epinephrine (Misr.co)
Topical cyclopentolate and phenylephrine
Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.
Drug: Topical cyclopentolate and phenylephrine
Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.
Other Name: Cyclophrine eye drops
- Intraoperative pupil diameter [ Time Frame: 1 day ]Intraoperative pupil diameter measurements of involved eye in mm
- Postoperative complications [ Time Frame: 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 corneal thickness [ Time Frame: 1 month after surgery ]Measured by specular microscopy in ( mm )
- Postoperative corneal endothelial density [ Time Frame: 1 month after surgery ]Measured by specular microscopy in ( cell number/mm2)
- Postoperative pupil diameter [ Time Frame: one day, one week and one month after surgery ]Postoperative diameter of involved eye in mm
- Postoperative visual acuity [ Time Frame: One day, one week and one month after surgery ]Postoperative best corrected distance visual acuity in logmar units.
- Postoperative intraocular pressure (IOP) [ Time Frame: One day, one week and one month after surgery ]Postoperative IOP measured in mmHg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638726
|Dar El Oyoun Hospital||Recruiting|
|Cairo, Giza, Egypt, 1261|
|Contact: Khaled Samir, MD|
|Principal Investigator:||Nossair||Dar El Oyoun Hospital|