Test results on the RUMEX OVD SUPREME performance
Product description:
SUPREME is a dispersive viscoelastic solution (OVD) of low molecular weight, a highly purified grade of hydroxypropyl methylcellulose (HPMC) 2%, clear, isotonic, sterile, non-inflammatory and non-pyrogenic in nature. It is used for intraocular injection during anterior segment surgery. The molecular weight is 86 000 Da. Viscosity is 3000 – 4500 cSt at 27° С.
Objectives:
1. To check whether the RUMEX OVD SUPREME can be completely removed from the anterior chamber after the phacoemulsification procedure is complete;
2. To check whether the intraocular pressure spikes take place during the postoperative period.
Patients and methods:
Forty-two eyes of 42 patients (71.6±7.7 years; 28 women and 14 men) that had grades 0 to 4 Emery–Little nuclear or cortical cataract without any other abnormalities were studied. The number of cases with glaucoma – 5. Phacoemulsification was performed using Alcon Infiniti. Intraocular pressure was measured with Alcon Infiniti. Huviz and Maklakov tonometer.
Table 1. The results of the IOP measurements with the tonometer before the surgery 1, 7 and 30 days after the surgery.
|
|
Intraocular pressure measurements, mmHg |
|||
|
Before the surgery |
1 day after the surgery |
7 days after the surgery |
30 days after the surgery |
|
|
1 |
16 |
14 |
15 |
15 |
|
2 |
18 |
16 |
16 |
16 |
|
3 |
18 |
17 |
17 |
17 |
|
4 |
21 |
18 |
18 |
18 |
|
5 |
22 |
20 |
20 |
20 |
|
6 |
20 |
18 |
18 |
18 |
|
7 |
21 |
20 |
20 |
20 |
|
8 |
24 |
27(+3mm) |
21 |
21 |
|
9 |
24 |
24 |
22 |
21 |
|
10 |
18 |
18 |
18 |
18 |
|
11 |
20 |
16 |
18 |
18 |
|
12 |
21 |
20 |
20 |
20 |
|
13 |
23 |
25(+2mm) |
21 |
21 |
|
14 |
25 |
21 |
21 |
21 |
|
15 |
20 |
24(+4mm) |
19 |
19 |
|
16 |
26 |
28(+2mm) |
22 |
22 |
|
17 |
18 |
22(+4mm) |
17 |
17 |
|
18 |
18 |
17 |
17 |
17 |
|
19 |
19 |
17 |
18 |
18 |
|
20 |
17 |
16 |
16 |
17 |
|
21 |
21 |
18 |
18 |
19 |
|
22 |
20 |
18 |
18 |
18 |
|
23 |
19 |
17 |
17 |
16 |
|
24 |
19 |
18 |
17 |
17 |
|
25 |
23 |
21 |
20 |
20 |
|
26 |
16 |
16 |
16 |
16 |
|
27 |
19 |
22(+3mm) |
18 |
19 |
|
28 |
20 |
20 |
20 |
20 |
|
29 |
20 |
18 |
18 |
18 |
|
30 |
21 |
19 |
19 |
19 |
|
31 |
22 |
20 |
20 |
20 |
|
32 |
22 |
21 |
20 |
20 |
|
33 |
19 |
17 |
17 |
17 |
|
34 |
18 |
24(+6mm) |
18 |
18 |
|
35 |
20 |
20 |
20 |
20 |
|
36 |
21 |
19 |
19 |
19 |
|
37 |
19 |
17 |
17 |
16 |
|
38 |
25 |
21 |
21 |
20 |
|
39 |
25 |
20 |
20 |
21 |
|
40 |
21 |
18 |
18 |
18 |
|
41 |
23 |
25(+2mm) |
22 |
22 |
|
42 |
18 |
16 |
16 |
16 |
Results:
A study reported (See Table 1) 19% (8 patients) incidence of IOP spikes (2-6 mmHg) 24 hours following phacoemulsification and IOL implantation. IOP level was stabilized 7 days following the cataract surgery and did not influence the postoperative eye condition and visual function of the patients. The IOP spike of 5 mmHg was observed in 1 patient diagnosed with glaucoma. The IOP spike of 2 mmHg was observed in 3 patients, all 3 diagnosed with glaucoma. The IOP spike of 3 mmHg was observed in 2 patients, one of them diagnosed with glaucoma. The IOP spike of 4 mmHg was observed in 2 patients, both had the grade 4 cataract.
The patients with IOP spikes of 4 to 6 mmHg were treated with antihypertensive drugs. The IOP was stabilized 7 days following the cataract surgery.
For most patients, the IOP decreased by 1- 4 mmHg one day postoperative. The most common complication in patients was cornea edema related to the high cataract grade, which has gone by the period up to 7 days postoperative.
To measure the rate at which residual OVD is removed from the anterior chamber, the amount of the BSS used for irrigation-aspiration after the IOL implantation was analyzed.
Table 2. The amount of BSS used for RUMEX OVD Supreme removal from the anterior chamber of the eye.
|
Patients |
The amount of BSS, ml |
Patients |
The amount of BSS, ml |
Patients |
The amount of BSS, ml |
|
1 |
12±1 |
15 |
10±1 |
29 |
10±1 |
|
2 |
15±1 |
16 |
12±1 |
30 |
10±1 |
|
3 |
9±1 |
17 |
12±1 |
31 |
9±1 |
|
4 |
10±1 |
18 |
11±1 |
32 |
12±1 |
|
5 |
13±1 |
19 |
12±1 |
33 |
13±1 |
|
6 |
12±1 |
20 |
13±1 |
34 |
13±1 |
|
7 |
10±1 |
21 |
14±1 |
35 |
12±1 |
|
8 |
12±1 |
22 |
11±1 |
36 |
12±1 |
|
9 |
11±1 |
23 |
12±1 |
37 |
11±1 |
|
10 |
11±1 |
24 |
13±1 |
38 |
10±1 |
|
11 |
12±1 |
25 |
11±1 |
39 |
12±1 |
|
12 |
11±1 |
26 |
12±1 |
40 |
12±1 |
|
13 |
13±1 |
27 |
13±1 |
41 |
11±1 |
|
14 |
11±1 |
28 |
14±1 |
42 |
13±1 |
According to the date in table 2, the average amount of BSS used for the complete removal of SUPREME from the anterior chamber of the eye is 12,2 +-1 ml.
Table 3. The data with the time spent for a surgery.
|
Patients |
Time spent for a surgery, min |
Patients |
Time spent for a surgery, min |
Patients |
Time spent for a surgery, min |
|
1 |
10 |
15 |
6 |
29 |
8 |
|
2 |
9 |
16 |
7 |
30 |
9 |
|
3 |
7 |
17 |
8 |
31 |
9 |
|
4 |
8 |
18 |
8 |
32 |
8 |
|
5 |
7 |
19 |
9 |
33 |
10 |
|
6 |
6 |
20 |
8 |
34 |
9 |
|
7 |
8 |
21 |
6 |
35 |
6 |
|
8 |
2 |
22 |
7 |
36 |
8 |
|
9 |
7 |
23 |
7 |
37 |
10 |
|
10 |
8 |
24 |
9 |
38 |
8 |
|
11 |
8 |
25 |
8 |
39 |
7 |
|
12 |
9 |
26 |
9 |
40 |
10 |
|
13 |
13 |
27 |
9 |
41 |
15 |
|
14 |
7 |
28 |
7 |
42 |
10 |
According to the test results showed in table 3, the average time needed for the RUMEX OVD Supreme removal from the anterior chamber is 8,5 min.
The fact of the complete removal of the OVD is checked with the help of the microscope during the surgery and after the surgery is complete.
Thus, RUMEX OVD Supreme is completely removed from the anterior chamber with the help of Balanced Salt Solution.
Conclusion:
The viscoelastic device SUPREME manufactured by RUMEX international LTD, United Kingdom, is completely removed from the anterior chamber of the eye with the Balanced Salt Solution.
The mild IOP spikes take place in patience 24 hours following the cataract surgery.
The IOP stabilizes within one week after the surgery.
Chief Extraordinary ophthalmologist
of Ministry of Health in Novgorod region D.V. Gatilov
14.02.2018