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The Effect of Intracameral Carbachol and Epinephrine on Choroidal Thickness

T

T.C. ORDU ÜNİVERSİTESİ

Status

Completed

Conditions

Choroid Disease
Cataract
Epinephrine Toxicity
Carbachol Adverse Reaction

Treatments

Procedure: Intracameral administration of epinephrine and carbachol during cataract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05225597
PANTONE 287 C

Details and patient eligibility

About

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.

Full 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.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

81 participants in 3 patient groups

epinephrine
Active Comparator group
Description:
In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision during cataract surgery
Treatment:
Procedure: Intracameral administration of epinephrine and carbachol during cataract surgery
carbachol
Active Comparator group
Description:
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
Treatment:
Procedure: Intracameral administration of epinephrine and carbachol during cataract surgery
control
No Intervention group
Description:
The control group was given neither epinephrine nor carbachol. Standard cataract surgery was performed

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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