Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05225597 |
Other study ID # |
PANTONE 287 C |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2021 |
Est. completion date |
December 30, 2021 |
Study information
Verified date |
February 2022 |
Source |
T.C. ORDU ÜNIVERSITESI |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.