Method for combination therapy of retinovascular macular oedema

FIELD: medicine.

SUBSTANCE: vasoendothelial growth factor inhibitor is introduced intravitreally (pars plana). That is followed by one-stage subthreshold micropulse laser coagulation 30 minutes later of the entire macular region, except for a central avascular zone in staggered circular lines. Distances of the laser coagulates in the entire area of exposure are equal to one coagulate. A laser processing of a perimacular area is further performed with a double distance of the laser coagulates and at lesser radiation power up to 800 mW short of 500 mcm to temporal vascular arcade in diabetic retinopathy, or upper or lower half of the perimacular area in thrombosis of a central retinal vein branch. The method provides higher early clinical effectiveness in the macular oedema until observing irreversible changes and stable visual deterioration, recovering the visual functions of the central retina by the atraumatic effect of the above laser parameters, treating the entire ischemic area and vascular retinal leakage.

EFFECT: administering vasoendothelial growth factor inhibitor provides recovery of the disturbed cytoarchitectonics of the evascular wall, reducing its permeability and transudation, desolating all the new vessels, reducing secondary oedemas of the optic disk.

2 dwg, 1 ex

 

The invention relates to medicine, namely to ophthalmology, and is intended for effective minimally invasive treatment of edema macular area of the retina vascular abnormalities occurred on the background of such eye diseases like diabetic retinopathy and thrombosis branches of the Central retinal vein.

Macular edema is a frequent and severe complication of diseases, which are based on the damage of the vascular wall (diabetic retinopathy, retinal vein thrombosis). This is the main reason for the decline in Central vision in these groups of patients, which in the natural course of or ineffectiveness of the treatment leads to the formation of pathological changes in the macular area, which, in turn, causes irreversible vision loss with persistent disability.

It is also known that panretinal laser coagulation of the retina, the need for which arises in the treatment of diabetic and postromanticism retinopathy, can increase the weight for macular edema. On what basis is recommended when the need for panretinal coagulation on the eyes with symptoms of macular edema to start with the treatment of the macular area (Early Treatment Diabetic Retinopathy Study).

Analogs

To reduce macular edema vascular Genesis (diabetic macular edema, edema of the macula in b is selected from thrombosis of the branches of the Central retinal vein) on treatment of the underlying disease, causing swelling, the most effective and widely used method is laser coagulation of the Central retina in type "grid", and intravitreal injections of corticosteroids (Diabetic Retinopathy Study; Early Treatment Diabetic Retinopathy Study; Standard Care vs. Corticosteroid for Retinal Vein Occlusion, 2009).

The technical essence of corticosteroids is transilience injection of triamcinolone acetonide in the vitreous cavity. Corticosteroids can reduce the permeability of blood vessels, preventing the failure hematopathology barrier, and reduce inflammation. They help reduce edema and improve visual acuity. However, the effect after injection unstable, in addition, the use of corticosteroids, especially long-term, leads to such negative side effects as the development of cataracts and glaucoma.

The technique of laser irradiation on the type of “grid”: coagulates size of 100 μm is applied on the area of edema, located at a distance of 1500 microns and more from foveola in several rows. To run the grid more periferica ranks are sometimes used coagulates size of 200 microns. When small areas of swelling coagulates placed at a distance of 2 diameters of the coagulate from each other. If the zone of significant edema, coagulates applied at a distance of 1 diameter of coagulate.

The limiting factor is and use coagulation of the retina in the macular and couples gulersoy region are:

- decreased visual acuity and contrast sensitivity of the retina;

- creeping atrophy of the pigment epithelium zones of coagulation;

- the formation of scars on the retina (more pronounced when exposed to an argon laser as compared with the diode laser infrared range) and, as a consequence, the relative and absolute defect of the Central visual field;

- the formation of epiretinal fibrosis and the risk of growth of neovascular membranes on the border of the laser coagulates (S.A. Kiire, S. Sivaprasad, V. Chong. 2011).

Prototype

As a prototype we have chosen "Method modified subproposal pharmacosmos micropotamogale of the retina in diabetic macular edema" (patent RF №2308920, Balashevich L.I., Siskin L.V., Gaza M.V., 2007).

The essence of the prototype method is the three-step laser action. First perform a test coagulation of the retina in the most distant from the center of the macula areas of edema using packets of pulses with a duration of 0.2 C. Pick up energy until barely visible burns. Then reduce exposure to 0.1 C. Then spend subproposal micropotamogale. When this is irradiated pigment epithelium of the retina under or in the immediate vicinity of the source local extravasation. Soborovanie the coagulates are placed at intervals equal to the diameter of the coagulate, two and bol the e series concentric around the source of leakage, within the whole local area of retinal edema. Then spend processing the entire area of the macula, free from swelling. The coagulates place in radial rows with spacing equal to the diameter of the coagulate, parafoveal with capture edge avascular zone.

The disadvantages of the prototype

1. The method prototype is only partially affects the pathogenesis retinovascular edema of the macula products atendofline growth factor important in the Genesis of macular edema, occurs not only at the level of the pigment epithelium of the retina (at the level of which is the effect of laser irradiation at subparagraph parameters), but also in its layers, and in endothelial cells of capillaries.

2. Also, it is somewhat time-consuming in practical use, since not all microaneurysms and zone of extravasation can be seen ophthalmoscopically for their sighting barrierefreie that requires a preliminary fluorescein angiography with subsequent mapping in the fundus.

3. In addition, application of lasercoagulation only on the area of macular edema may be less effective in terms of long-term stable treatment results, due to the fact that the pathological changes leading to the development of macular edema, occur in perimacular the area where fluid prosci is highlighted and again accumulates in the macula.

Purpose

The aim of the proposed method combined treatment retinovascular macular edema is to increase the effectiveness of treatment of edema of the macula in the early period, before the occurrence of irreversible changes and permanent vision loss. Providing simultaneously high efficiency anatomical restoration of the macula and possible traumas of the suggested treatment to achieve improvement of visual functions of the Central zone of the retina.

The essence of the proposed method

The essence of the proposed method of treatment is illustrated in figure 1 (thrombosis of the superior temporal branch of the Central retinal vein) and figure 2 (nonproliferative diabetic retinopathy with diabetic macular edema), where position 1 is the Central avascular area of the retina together with foveolae; 2 is a schematic drawing of the laser coagulates the area of macular edema (padmakumara laser coagulation); 3 is a circuit drawing of a laser coagulates in perimacular zone and distal to 500 μm from the temporal vascular arcades (extended perimacular laser coagulation). In reality, the laser coagulates when conducting impulse subproposal coagulation of the proposed method is not visualized ophthalmoscopically.

The method is intended for the treatment of macular edema retinal vascular abnormalities in nichego against the background of such eye diseases, as diabetic retinopathy and thrombosis branches of the Central retinal vein, and is a two-component combined method of treatment, comprising conducted sequentially treatment stages, with an interval in time between the first and second stage 30 minutes

stage 1 consists of the following: intravitreal (pars plana) to introduce the inhibitor atendofline growth factor - ranibizumab (0.5 mg).

stage 2 is panicularly and extended perimacular impulse subproposal laser coagulation, namely: cause of circular rows of laser coagulates in a checkerboard pattern on the entire area of the macula and perimacular area up to 500 μm from the temporal vascular arcades infrared laser with a wavelength of 810 nm in impulse subproposal mode. The ranks of the laser coagulates from the borders of the Central avascular zone and one row outwards from the outer boundaries of macular edema performed with the following parameters:

- the diameter of the coagulate 100 microns

- the distance between coagulates equal to the diameter of coagulate

- exposure time of 300 MS

- duty cycle 5%

- power 1 watt

- the duration of microimpulse 100 μs.

Then, from the outer circular series of laser coagulates and not far from 500 μm to the temporal vascular arcades and borders of the optic nerve head (360° in diabetic retinopathy and 180° when the blood clot is ze branches of the Central retinal vein, in the upper or lower half of the fundus, respectively, localization of venous thrombosis), use the following parameters extended perimacular laser photocoagulation:

- the diameter of the coagulate 150 microns

- the distance between coagulates equal to two diameters of the coagulate

- exposure time of 150 MS

- duty cycle 5%

- power 800 mW

- the duration of microimpulse 100 μs.

The features of the invention, distinguishing it from the prototype

1. Unlike the prototype, panicularly laser coagulation is conducted in three stages, and at one stage, which greatly simplifies the task of the surgeon and reduces the duration of the operation.

2. The proposed method panicularly laser coagulation spend circular rows in a checkerboard pattern. Thus the distance between the laser coagulates over the entire area of impactequal to one coagulate. This eliminates the need for laser barrierefreie around each microaneurysms, as in the method prototype in which panicularly laser coagulation spend radial rows, with a distance between coagulates may be different.

3. Unlike the prototype, we use low-energy extended perimacular laser, which provides the increase of absorption at the level of the pigment epithelium/choriocapillaris and sposobem the em low levels of growth factors total area of the retina, involved in the pathological process.

4. This method of treatment in contrast to the prototype provides, in addition to laser treatment of the retina, prior intravitreal injection of inhibitor atendofline factorgrowth that allows to obtain more rapid, complete and lasting restoration of anatomy of the macula.

A specific example of the application

Patient Hajiyev M.V., 58 years old, medical history, No. 284, was hospitalized in OOO Eye Clinic "High tech" with 5.03.2012, at 19.03.2012,

DS: OU: nonproliferative diabetic retinopathy, primary complicated cataract, OD: diabetic macular edema.

Visus: OD=0.4 sec/sph+0,75 d=0,5

OS=0,8 n/a

Upon receipt.

Biomicroscopy OD: transparent cornea, anterior chamber average depth of moisture clean, pupil 3 mm in diameter, photoreaction, in the lens opacities predominantly in the cortical layers.

Stereoscopic ophthalmoscopy OD: optic nerve disc pale pink, clear boundaries, the vascular bundle from the center, petechial and petechial haemorrhages in the retina, the deposition of hard exudates in the Central area of the fundus. In the macula reflexes are not differentiated, turbidity, stereoscopically determined prominence. Optical coherence tomography of the retina OD: rarefaction layers of the retina in the macular region with the participation is com serous detachment of the neuroepithelium. The height of the macula, 324 μm. 8.03.2012, was carried out two-component therapeutic intervention on his right eye: local anesthesia of 0.5% of Alcina. 4 mm from the limbus in the upper outer quadrant was performed injection (pars plana) with the introduction of intravitreal 0.5 mg ranibizumab, prophylactic subconjunctival antibiotics, the imposition of antiseptic dressings. After 30 min was carried out subprograma impulse laser coagulation under local anesthesia with 0.5% solution of alcaine using the contact laser lenses Reichel - Mainster 1×(0,95×) infrared diode laser (IRIS Medical IQ 810 (IRIDEX) by the proposed method.

Through 1 month after the intervention.

Visus: OD=0.6 s/sph+0,50 d=0,7-0,8

OS=0,8 n/a

Biomicroscopy OD: transparent cornea, anterior chamber average depth of moisture clean, pupil 3 mm in diameter, photoreaction, in the lens opacities predominantly in the cortical layers. The vitreous body is transparent.

Stereoscopic ophthalmoscopy OD: optic nerve disc pale pink, clear boundaries, the vascular bundle of the center; small residual deposits of hard exudates.

Ophthalmoscopically macular edema is not defined.

Optical coherence tomography of the retina OD: normal profile of the macula, a small vacuum layers of the retina in the macular region. The height of the macula, 189 microns.

Computer static is th perimetry OD: increased Central sensitivity of the retina - with 421 dB to 537 dB. The emergence of relative and absolute cattle not detected.

Advantages of the method

1. Using the specified parameters of the laser eliminates the possibility of damage to the neurosensory layers of the retina, directly in the area of laser photocoagulation and adjacent areas, regardless of the degree of pigmentation of the retina (Luttrull J., Sramek, Palanker D, Spink CJ, Musch DC, Department of Ophthalmology, School of Medicine and Hansen Experimental Physics Laboratory, Stanford University, Palo Alto, California, USA. "Long-term safety, high-resolution imaging, and tissue temperature modeling of subvisible diode micropulse photocoagulation for retinovascular macular edema." // Retina 32:375-86. 2012), which allows to achieve a significant improvement not only anatomical but also functional.

2. In the repeat mode of the series of low-energy microsurge energy of each subsequent pulse is accumulated inside the target tissue, thus achieving a therapeutic effect similar to that threshold methods of coagulation, but without their inherent complications.

3. Using the extended perimacular low-energy laser irradiation allows to treat the entire area of ischemia and vascular leakage in the retina, thereby improving chorioretinal metabolism and absorption of intra - and subretinal fluid (thrombosis branch DCS ischemia, liking develop due to venous stasis in the area of the retina corresponding to "is " off " the" Vienna; in diabetic retinopathy pathological changes in the vascular walls of the capillaries also lead to likego and discharge of blood precapillary anastomoses with the development of ischemia of the retina), as well as reducing the ischemia of the retina (which is the main producer of factors of neoangiogenesis, the cause of progression of retinopathy and persistence of macular edema)due to death in the impact zone nonviable cells of the pigment epithelium, without narrowing the field of view or education cattle.

4. Intravitreal injection of inhibitor atendofline growth factor promotes the restoration cytoarchitectonic vascular wall, reducing its permeability and extravasation, and zapustevanie pathological neovessels. The introduction of the inhibitor atendofline growth factor in combination with laser exposure, which increases the absorbance already leaked fluid, gives a pronounced effect in the treatment of macular edema.

5. The use of inhibitors atendofline growth factor, also significantly reduced the secondary edema of the optic nerve, which facilitates venous return and, in turn, promotes the resorption of swelling of the macula.

The method of combined treatment retinovascular macular edema, which consists in a two-component therapeutic in the action, characterized in that the first patient is injected intravitreally (pars plana) inhibitor atendofline growth factor and after 30 min spend subproposal impulse laser coagulation in a single step, first, the entire area of the macula, with the exception of the Central avascular zone, circular rows in a checkerboard pattern, with the distance between the laser coagulates over the entire area of impact is equal to one coagulate, then double the interval between the laser coagulates and with a reduced radiation power up to 800 mW carry out laser processing perimacular zone, not far from 500 μm to the temporal vascular arcades in diabetic retinopathy, either the upper or lower half of the zone perimacular thrombosis of a branch of the Central retinal vein.



 

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