The Effect of Intracameral Carbachol and Epinephrine on Choroidal Thickness

Not Applicable

Completed

• Conditions: Choroid Disease; Epinephrine Toxicity; Cataract; Carbachol Adverse Reaction
• Interventions: Procedure: Intracameral administration of epinephrine and carbachol during cataract surgery

• Registration Number: NCT05225597
• Lead Sponsor: T.C. ORDU ÜNİVERSİTESİ

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.

Detailed Description

This study consisted of three groups: epinephrine group, carbachol group, and control group. Intracameral carbachol and epinephrine was not used for complication management. In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision. 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. The control group was given neither epinephrine nor carbachol.

Mydriasis was induced using combined 2.5% phenylephrine and 1.0% tropicamide topical drops before surgery. All surgeries were performed by the same surgeon (HBK) 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. A combination of 1.6% sodium hyaluronate and 4% chondroitin sulfate (ophthalmic viscosurgical device, Discovisc, Alcon Laboratories, Inc.) was used during capsulorhexis in all three groups, and Alcon Infiniti System (Alcon Laboratories Inc.) was used for phacoemulsification. A continuous curvilinear capsulorhexis of 4.5-5.5 mm was created. 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 in irrigation/aspiration mode. Before implanting a one-piece foldable hydrophobic acrylic 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. Topical moxifloxacin, nepafenac, and prednisolone acetate eye drops were given to all patients six times a day for the first week. Prednisolone acetate was then reduced and discontinued 4 weeks after the operation.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-12-30
• Study First Submitted: 2022-01-14
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• over 18 years old
• patients with cataracts

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbachol	Intracameral administration of epinephrine and carbachol during cataract surgery	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
epinephrine	Intracameral administration of epinephrine and carbachol during cataract surgery	In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision during cataract surgery

Primary Outcome Measures

Name	Time	Method
choroidal thickness(CT)	preoperatively, on postoperative day 1, and in postoperative week 1	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.

Secondary Outcome Measures

Name	Time	Method
intraocular pressure	before, 1 day, and 1 week after surgery	Intraocular pressure was measured in all patients using a non-contact tonometer.

Trial Locations

Locations (1)

Ordu University; 🇹🇷 Ordu, ABD Dışında, Turkey