CLINICAL EVALUATION OF THE EFFICACY OF AZOXIME BOVIOLALURONIDASE IN THE PREVENTION OF EXCESSIVE SCARRING AFTER SURGICAL TREATMENT OF GLAUCOMA

PURPOSE: To study the efficacy and safety of “Longidaze® lyophilsate for solution for injections 1500 IE” in subconjunctival injections for wound healing regulation after glaucoma surgery.

METHODS: 90 patients (90 eyes) with primary openangle glaucoma, demanding repeated trabeculectomy, were enrolled into study. Average baseline IOP was 28.7±9.8 mmHg, average amount of hypotensive drugs was 2.6±0.5. All the patients underwent primary trabecu-lectomy in the course of last 6 months.

Patients were randomized into 3 groups: group 1 received one Longidaze® injection 7 days after trabeculectomy; group 2 received 2 Longidaze® injections — 7 and 14 days after trabeculectomy respectively; group 3 received common antiinflammatory postoperative treatment (dexamethasone and tobramycin fixed combination (“Tobradex”) and nepafenac solution (“Nevanak”) 4 times daily for 1 month).

Before the operation, and 6 and 12 months after visometry, static perimetry and confocal retinal tomography were performed. In 1 day, 1 week, 1, 3, 6 and 12 months after the operation tonometry, hemoglobin saturation (SO₂) assessment and computerized evaluation of filtration zone hyperemia were performed.

RESULTS: On the first day after trabeculectomy the SO₂ level decreased approximately by 1/3 in all groups with a significant difference between groups 1 and 3 (р=0.0166), showing a recovery trend in 1 week. In group 2 SO₂ level had been decreasing since month 1 till month 3 after trabeculectomy. The SO₂ difference between groups during the other periods wasn’t statistically significant.

By the end of the first month after the surgery hyperemia level in group 1 decreased from 27.3±4.3 to 23.5±4.4%. A repeated injection in group 2 maintained hyperemia at the initial level. In the control group hyperemia level decreased significantly from 26.9±4.5 to 18.1±3.2% (the difference between groups is significant in all cases). A significant decrease of hyperemia (11.9±3.2, 11.5±3.6 and 12.0±3.4%) occurred by month 3 without any significant difference between groups, with overall hyperemia level returning to normal by month 6.

The filtering bleb assessment according to the Wuerzburg bleb classification score revealed the indices’ normalization by the end of the first month after trabeculectomy with a significant advantage in groups 1 and 2 (9.52±1.48 and 9.15±1.67; 8.53±1.83 incontrol group), maintaining the trend during the first year.

IOP level didn’t differ in the groups till month 3. By month 6 IOP level in the control group increased by 1.1-1.3 mmHg without significant difference.

Absolute trabeculectomy success (reaching target IOP without hypotensive drugs and needling) equaled 82, 81 and 70% in groups 1, 2 and 3 correspondingly. Qualified trabeculectomy success with postoperative use of needling and hypotensive therapy appeared to be comparable, equaling 86, 84 and 87%. Complications rate didn’t differ significantly between the groups.

CONCLUSION: The study results confirm a high level of injury associated with repeated trabeculectomy. Both single and repeated Longidaze® injections didn’t significantly affect the oxygen metabolism in the filtration zone. Longidaze® injection slightly slowed the decrease of hyperemia, which appeared in the control group 1 week after the surgery. A significant negative linear dependency between SO₂ level and filtration zone hyperemia was detected in all groups, revealing a close connection between hyperemia level and oxygen consumption by the tissues.

According to the Wuerzburg bleb classification score, blebs characteristics in groups 1 and 2 during the follow-up period exceeded those of the control group. No significant difference between 1 or 2 injections was noted in terms of IOP change.

Subconjucntival LongidazeR injections generally do not affect the postoperative complications rate, related to trabeculectomy.

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