Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

D

Dar El Oyoun Hospital

Status and phase

Unknown
Phase 4

Conditions

Adverse Drug Event
Cataract
Mydriasis

Treatments

Drug: Atropine sulfate and epinephrine
Drug: Topical cyclopentolate and phenylephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT03638726
IRB 00001211

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Atropine sulfate and Epinephrine
Experimental group
Description:
Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist).
Treatment:
Drug: Atropine sulfate and epinephrine
Topical cyclopentolate and phenylephrine
Other group
Description:
Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.
Treatment:
Drug: Topical cyclopentolate and phenylephrine

Trial contacts and locations

1

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Central trial contact

Ewais; Ali

Data sourced from clinicaltrials.gov

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