Nowadays, local corticosteroids still remain the gold standard for treatment of postoperative aseptic inflammation, particularly after operations on the anterior eye segment for cataract and glaucoma. This is assigned as decisive factor for fast and full recovery of sight. Despite high therapeutic effectiveness of corticosteroid preparations, their usage is still restricted because of number of side effects such as their ability to raise intraocular pressure, damaging lens transparency, weakening of local immune response and rising risk of infection development, interrupting wound healing process.
Nonsteroidal anti-inflammatory preparations, with highly expressed anti-inflammation effect, do not have some of shortcomings of corticosteroids. Diclofenac sodium is the most effectiveness among nonsteroidal anti-inflammatory drugs and it is very perspective preparation for treating various ophthalmopathies: It deals with postoperative aseptic inflammation (after cataract surgery, radial keratotomy, Argon Laser Trabeculoplasty) (5,6), lengthen mydriasis (7), has analgesic effect and do not influence on intraocular pressure, it is also used to treat damaged cornea. Mechanism of action of non-steroidal anti-inflammatory drugs is blockage of synthesis of ciclooxygenase and lipooxygenase pathway mediators from arachidonic acid.
Flurbiprofen, Indometacin, ketorolac, and Diclofenac sodium belong to frequently used non-steroidal anti-inflammatory drugs. It is stated that Diclofenac Sodium differs from other drugs of this group by its best therapeutic effect and good tolerance (10).
The goal of our clinical trial is to study effectiveness of Diclofenac sodium 0,1% (Clodifen) eye drops in contrast of corticosteroid dexamethasone phosphate (Medexol), for treatment of postoperative inflammation after cataract surgery with implantation of artificial lens.
Data and methods
62 patients (27 women and 35 men) were enrolled in clinical trial. All of them were operated for cataract with intraocular implantation of lens in posterior eye chamber. Patients age was between 45-92 years (mean of 63, 6 years). Inclusion criteria were age of more than 40 years and uncomplicated surgery. Exclusion criteria were diabetic retinopathy, increased intraocular pressure (25mmHg), previous intraocular intervention, pseudoexfoliations, usage of other preparations, allergic reaction on NSAIDs, and complicated surgery.
Following ophthalmologic investigations were made: visometric, eye biomicroscopic, ophthalmoscopic and tonometric examinations. These investigations were conducted before treatment and on 1st, 3rd, and 7th, 14th postoperative days and after a month of operation. During examination following were evaluated:
Ø pain syndrome relief by studied drug (patient’s subjective feeling)
Ø periods of disappearance of signs of inflammation (transparency of anterior chamber liquid and etc.)
Ø Frequency and character of postoperative complications (folds of cornea and descement membrane, presence of mixed conjunctival injections.)
Surgical intervention was standard cataract surgery with extra capsular extraction with implantation of artificial lens in posterior chamber (all lenses were PMMA): Corneoscleral incision on cornea, anterior capsulotomy, nucleus evacuation, aspiration of lens materials and implantation of artificial lens in capsular pouch was made. Patients were divided in two groups: with 31 patients in each group. Patients of I group have been receiving diclofenac sodium 0.1% (Clodifen) eye drops 1-2 drops 4 times a day and patients of II group have been receiving dexamethasone phosphate 0.1% (Medexol) eye drops 1-2 drops 4 times a day. This treatment regimen continued for 1 month after operation until disappearance of all signs of inflammation.
Influence of diclofenac sodium 0,1% (Clodifen) and dexamethasone phosphate 0,1% (Medexol) on postoperatively developed aseptic inflammation was studied in 62 patients involved in clinical trial. All included patients had good tolerance to used preparations and did not have any discomfort or other complaints upon instillation. They did not complain for pain or corneal syndrome from the very next day of the operation.
The most common symptom of developed inflammation was descemetitis, which was revealed from the first day in 16 patients of group I -39.7% (12/31) and in 11 patients of group II – 35, 4% (11/31). Amelioration of descemetitis began from 3-8 days from the operation and only 2 patients of group I -6, 4% (2/31) and 1 patient of group II 3,2% (1/31) have symptoms on the eighth day. The difference between two groups was not statistically convincing (p< 0, 35).
Change in intraocular pressure toward ophthalmohypertension direction was detected in 3 patients from both groups on the second day and this led to slight swelling of cornea. But pressure improved on 2nd -3rd days and it did not demand any further antihypertensive treatment.
There was detected some exudations in anterior chamber in the form of delicate membrane in pupil area in 3 patients of group I (9, 7%) and 2 patients of group II (6, 6%). With treatment, membrane fibers disappeared and pupil zone became transparent with consequent sight improvement on day 8. Conjunctival injection disappeared on approximately day 3,1 ±0,28
Improvement of vision in particular time period was in correlation of decreasing of signs of inflammation and difference between two groups was not statistically convincing, vision acuity of 0, 5 - 0,6 was in most cases of both groups after one month and tendency to improvement was detected after removing the corneal sutures.
There was not demonstrated any side effects during safety analyses of Clodifen and Medexol usage or any patients’ complaints about inconvenient feelings upon usage of these medications.
Nowadays Diclofenac sodium is the powerful non-steroidal anti-inflammatory agent, which do not have side effects in contrast to corticosteroids (increase of intraocular pressure or disturbing postoperative wound healing process). There is shown is some studies that Diclofenac sodium usage is effective for controlling postoperative inflammation processes, which develops after injuring of the hemato-ophthalmic barrier.
While the anti-inflammatory effects of corticosteroids is accomplished in several different ways and inhibition of arachidonic acid is one of them, NSAIDs specifically decrease inflammation by inhibiting cyclooxygenase activity and prevent release of prostaglandins from arachidonic acid. But in contrast of other NSAIDs diclofenac sodium indirectly modulates lipooxygenase chain in arachidonic acid cascade. The dual mechanism of action of Diclofenac gives opportunity to compare it with corticosteroids.
Assessment of anti-inflammatory effects of Clodifen and Medexol was made on the basis of biomicroscopic examination and patients’ subjective feelings. The main criteria for estimation of postoperative inflammation processes were decreasing number of cells in the liquid and the lessening the cloudiness of anterior chamber liquid. Based on the parameters evaluated, this included aseptic inflammation, conjunctival injection, corneal swelling, increase of intraocular pressure and study of changes of vision, relatively positive dynamics were revealed in both groups, with treatment both by Diclofenac sodium and Dexamethasone phosphate. No statistically convincing difference was found between two groups (p<0, 35).
The study showed similar effectiveness of Clodifen and Medexol to control aseptic inflammation, which is important to prevention such possible complications as corneal lesions and cystic swelling of the macula. By using diclofenac sodium possible complications of corticosteroids can be avoided (secondary infections, increased intraocular pressure) and based on the clinical situation physician have opportunity to choose.
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