The Effect of Intracameral Carbachol and Epinephrine on Choroidal Thickness

NCT05225597 | Completed

• 1 other identifier: PANTONE 287 C
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

81 eyes of 81 patients undergoing cataract surgery were included in this prospective interventional study. During cataract surgery, intracameral carbachol was applied to 27 eyes, intracameral epinephrine was administered to 20 eyes and 34 eyes were the control group. Macular choroidal thickness measurement was performed before, 1 day, and 1 week after phacoemulsification surgery in all patients using optical coherence tomography.

Conditions

Epinephrine Toxicity; Cataract; Carbachol Adverse Reaction; Choroid Disease

Keywords

choroidal thickness; carbachol; epinephrine; phacoemulsification; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• choroidal thickness(CT)

  CT measurement was performed using a Cirrus HD(high definition) 500 spectral OCT (optical coherence tomography) platform (Carl Zeiss Meditec, Dublin, California, USA). Subfoveal, nasal, temporal, lower choroidal thickness, and upper choroidal thickness were measured manually by two blinded observers with 0.5-mm intervals in vertical and horizontal sections having a length of 4 mm. The distance between the outer hyper-reflective border of the retinal pigment epithelium and the inner scleral surface was considered. Average data obtained by two observers were used in statistical analysis.

  preoperatively, on postoperative day 1, and in postoperative week 1

Secondary Outcomes (1)

• intraocular pressure

  before, 1 day, and 1 week after surgery

Study Arms (3)

epinephrine

ACTIVE COMPARATOR

In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision during cataract surgery

Procedure: Intracameral administration of epinephrine and carbachol during cataract surgery

carbachol

ACTIVE COMPARATOR

In the carbachol group, a 0.5 ml dose of 0.01% carbachol solution (Miostat®, Alcon Laboratories, Inc., Fort Worth, TX) was given intracamerally immediately after viscoelastic matter removal following IOL implantation

Procedure: Intracameral administration of epinephrine and carbachol during cataract surgery

control

NO INTERVENTION

The control group was given neither epinephrine nor carbachol. Standard cataract surgery was performed

Interventions

Intracameral administration of epinephrine and carbachol during cataract surgery PROCEDURE

All surgeries were performed by the same surgeon using a similar technique, under topical anesthesia (0.05% proparacaine HCL), and with a 2.8 mm temporal clear corneal incision. After making the incision, 0.2 mL of preservative-free epinephrine (1:5000) was injected into the epinephrine group only. After complete hydrodissection, the nucleus was removed using the stop and chop technique. Phacoemulsification time (range: 30-60 s) was similar in all patients, while the phacoemulsification strength was set to 35%-40% for all operations. The cortex was aspirated. Before implanting a one-piece foldable hydrophobic acrylic intraocular lens (IOL) into the capsular bag, 1% sodium hyaluronate (ophthalmic viscosurgical device, Healon) was injected into the capsular bag. After removal of the viscoelastic material, only the carbachol group was given 0.5 ml of 0.01% carbachol solution intracamerally. Hydration with balanced salt solution was used to close the corneal incisions.

carbachol; epinephrine

Eligibility Criteria

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

You may qualify if:

• over 18 years old
• patients with cataracts

You may not qualify if:

• hypertension and diabetes
• ocular problems such as uveitis, glaucoma, amblyopia
• maculopathy, retinal dystrophy
• any previous ocular surgery
• eye trauma
• congenital cataracts

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University

Ordu, ABD Dışında, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cataract; Choroid Diseases

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Uveal Diseases

Study Officials

• Hasan B Kaptı, MD

  Ordu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were unaware of the group in which they were assigned. The person evaluating the results did not know which result belonged to which group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study consisted of three groups: epinephrine group, carbachol group, and control group.

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 4, 2022
• Study Start: January 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)