NCT03638726

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 28, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

February 5, 2018

Last Update Submit

October 7, 2018

Conditions

CataractMydriasisAdverse Drug Event

Keywords

intraoperative mydriasissubconjunctival atropineintracameral epinephrinecataract surgery

Outcome Measures

Primary Outcomes (1)

  • Intraoperative pupil diameter

    Intraoperative pupil diameter measurements of involved eye in mm

    1 day

Secondary Outcomes (6)

  • Postoperative complications

    Starting from first postoperative day till one month.

  • Postoperative corneal thickness

    1 month after surgery

  • Postoperative corneal endothelial density

    1 month after surgery

  • Postoperative pupil diameter

    one day, one week and one month after surgery

  • Postoperative visual acuity

    One day, one week and one month after surgery

  • +1 more secondary outcomes

Study Arms (2)

Atropine sulfate and Epinephrine

EXPERIMENTAL

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

Topical cyclopentolate and phenylephrine

OTHER

Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.

Drug: Topical cyclopentolate and phenylephrine

Interventions

Atropine sulfate and epinephrineDRUG

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)
Atropine sulfate and Epinephrine
Topical cyclopentolate and phenylephrineDRUG

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

Also known as: Cyclophrine eye drops
Topical cyclopentolate and phenylephrine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases of bilateral visually significant cataract

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dar El Oyoun Hospital

Cairo, Giza Governorate, 1261, Egypt

RECRUITING

MeSH Terms

Conditions

CataractMydriasisDrug-Related Side Effects and Adverse Reactions

Interventions

AtropineEpinephrineCyclopentolatePhenylephrine

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesPupil DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingEthanolaminesAmino AlcoholsAlcoholsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Nossair

    Dar El Oyoun Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewais

CONTACT

+01223638543waelewais74@gmail.com

Ali

CONTACT

+01005005707

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Preoperative and postoperative assessment will be done by a masked observer.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized clinical study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology, Cairo University

Study Record Dates

First Submitted

February 5, 2018

First Posted

August 20, 2018

Study Start

September 28, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

EG(1)