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Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco

Primary Purpose

Corneal Endothelial Cell Loss, Mydriasis, Cataract

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Corneal Endothelial Cell Loss focused on measuring corneal endothelial cell count, Fydrane, mixed mydriatic and anaesthetic combination, intracameral mydriatic, mydriasis, phacoemulsification

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • medium density cataract (nuclear II to III)

Exclusion Criteria:

  • soft or hard density cataract (nuclear I or IV)
  • history of ocular trauma or previous intraocular surgery
  • iatrogenic, congenital or traumatic cataract
  • associated eye disease e.g. pseudoexofoliation syndrome
  • associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy
  • associated systemic disease that can affect endothelium,

Sites / Locations

  • Cairo University - Kasr Alainy hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Fydrane group

Reference group:

Arm Description

Fydrane is injected intracamerally at the beginning of cataract surgery after the first incision, at a dose of 0.2 ml of solution, in only one injection. Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). No preoperative topical eye drops are used.

not injected with intracameral Fydrane. Pupillary dilatation in this group is achieved using preoperative topical eye drops: cyclopentolate hydrochloride 1% and tropicamide 1 % one drop every 15 min for 1 hour preoperatively.

Outcomes

Primary Outcome Measures

safety of intracameral Fydrane on endothelial cell count
evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative

Secondary Outcome Measures

effect of Fydrane on pupil diameter during phacoemulsification
Fydrane Efficacy in achieving and maintaining mydiasis, is evaluated by measuring pupil diameter using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)

Full Information

First Posted
May 15, 2020
Last Updated
May 19, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04396301
Brief Title
Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco
Official Title
Effect of Intracameral Injection of Preservative Free, Fixed Concentration of Combined Mydriatic Plus Anaesthetic Formulation on Corneal Endothelial Cell Count in Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.
Detailed Description
in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15 eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes (Reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Endothelial Cell Loss, Mydriasis, Cataract
Keywords
corneal endothelial cell count, Fydrane, mixed mydriatic and anaesthetic combination, intracameral mydriatic, mydriasis, phacoemulsification

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fydrane group
Arm Type
Active Comparator
Arm Description
Fydrane is injected intracamerally at the beginning of cataract surgery after the first incision, at a dose of 0.2 ml of solution, in only one injection. Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). No preoperative topical eye drops are used.
Arm Title
Reference group:
Arm Type
No Intervention
Arm Description
not injected with intracameral Fydrane. Pupillary dilatation in this group is achieved using preoperative topical eye drops: cyclopentolate hydrochloride 1% and tropicamide 1 % one drop every 15 min for 1 hour preoperatively.
Intervention Type
Drug
Intervention Name(s)
Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
Other Intervention Name(s)
Mydrane
Intervention Description
Fydrane®. The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide type local anaesthetics) for each 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride for 1 ml.
Primary Outcome Measure Information:
Title
safety of intracameral Fydrane on endothelial cell count
Description
evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative
Time Frame
3 weeks postoperative
Secondary Outcome Measure Information:
Title
effect of Fydrane on pupil diameter during phacoemulsification
Description
Fydrane Efficacy in achieving and maintaining mydiasis, is evaluated by measuring pupil diameter using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)
Time Frame
pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: medium density cataract (nuclear II to III) Exclusion Criteria: soft or hard density cataract (nuclear I or IV) history of ocular trauma or previous intraocular surgery iatrogenic, congenital or traumatic cataract associated eye disease e.g. pseudoexofoliation syndrome associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy associated systemic disease that can affect endothelium,
Facility Information:
Facility Name
Cairo University - Kasr Alainy hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco

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