Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03638726
• Other study ID #: IRB 00001211
• Status: Recruiting
• Phase: Phase 4
• Start date: September 28, 2018
• Est. completion date: June 2019

Study information

• Verified date: October 2018
• Source: Dar El Oyoun Hospital
• Contact: Ewais
• Phone: +01223638543
• Email: waelewais74[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adverse Drug Event
• Cataract
• Drug-Related Side Effects and Adverse Reactions
• Mydriasis

Intervention

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.
• Topical cyclopentolate and phenylephrine
Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.

Locations

Country	Name	City	State
Egypt	Dar El Oyoun Hospital	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Dar El Oyoun Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative pupil diameter	Intraoperative pupil diameter measurements of involved eye in mm	1 day
Secondary	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.
Secondary	Postoperative corneal thickness	Measured by specular microscopy in ( mm )	1 month after surgery
Secondary	Postoperative corneal endothelial density	Measured by specular microscopy in ( cell number/mm2)	1 month after surgery
Secondary	Postoperative pupil diameter	Postoperative diameter of involved eye in mm	one day, one week and one month after surgery
Secondary	Postoperative visual acuity	Postoperative best corrected distance visual acuity in logmar units.	One day, one week and one month after surgery
Secondary	Postoperative intraocular pressure (IOP)	Postoperative IOP measured in mmHg	One day, one week and one month after surgery