Clinical trial NCT05225597: The Effect of Intracameral Carbachol and Epinephrine on Choroidal Thickness
Official title: The Effect of Intracameral Carbachol and Epinephrine Use on Choroidal Thickness After Uncomplicated Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epinephrine Toxicity
Cataract
Carbachol Adverse Reaction
Choroid Disease
Keywords: choroidal thickness
carbachol
epinephrine
phacoemulsification
optical coherence tomography
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study consisted of three groups: epinephrine group, carbachol group, and control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: choroidal thickness(CT)
timeFrame: preoperatively, on postoperative day 1, and in postoperative week 1
Secondary outcomes:
measure: intraocular pressure
timeFrame: before, 1 day, and 1 week after surgery
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
state: ABD Dışında
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Hasan B Kaptı, MD
role: PRINCIPAL_INVESTIGATOR
References: