Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

Sponsor

Dar El Oyoun Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03638726

Collaborator

(none)

Enrollment

Location

Arms

8.1

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Mydriasis Adverse Drug Event	Drug: Atropine sulfate and epinephrine Drug: Topical cyclopentolate and phenylephrine	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical studyRandomized clinical study

Masking:

Single (Outcomes Assessor)

Masking Description:

Preoperative and postoperative assessment will be done by a masked observer.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 28, 2018

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Atropine (Misr.co), Epinephrine (Misr.co)
Other: 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 Names: Cyclophrine eye drops

Arm

Intervention/Treatment

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 Names:

Atropine (Misr.co), Epinephrine (Misr.co)

Other: 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 Names:

Cyclophrine eye drops

Outcome Measures

Primary Outcome Measures

Intraoperative pupil diameter [1 day]
Intraoperative pupil diameter measurements of involved eye in mm

Secondary Outcome Measures

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 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 pupil diameter [one day, one week and one month after surgery]
Postoperative diameter of involved eye in mm
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).