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

NCT04396301 | Completed Phase 3

• 1 other identifier: CU-oph-02-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Endothelial Cell Loss; Mydriasis; Cataract

Keywords

corneal endothelial cell count; Fydrane; mixed mydriatic and anaesthetic combination; intracameral mydriatic; mydriasis; phacoemulsification

Outcome Measures

Primary Outcomes (1)

• 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

  3 weeks postoperative

Secondary Outcomes (1)

• effect of Fydrane on pupil diameter during phacoemulsification

  pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)

Study Arms (2)

Fydrane group

ACTIVE COMPARATOR

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.

Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).

Reference group:

NO INTERVENTION

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.

Interventions

Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). DRUG

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.

Also known as: Mydrane

Fydrane group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• medium density cataract (nuclear II to III)

You may not qualify if:

• 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,

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University - Kasr Alainy hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Corneal Endothelial Cell Loss; Mydriasis; Cataract

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pupil Disorders; Lens Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: February 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

EG (1)