Possibilities and effectiveness of cataract phacoemulsification, closed subtotal vitrectomy and panretinal laser coagulation in diabetic maculopathy treatment in patients with type 2 diabetes

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Possibilities and effectiveness of cataract phacoemulsification, closed subtotal vitrectomy and panretinal laser coagulation in diabetic maculopathy treatment in patients with type 2 diabetes

Panchenko Yu. A.

PhD, Candidate of Medical Sciences, a doctor in Kyiv Clinical Ophthalmology Hospital “Eye Microsurgery Center "

Summary

The article presents the findings of studying the possibilities and effectiveness of cataract phacoemulsification, closed subtotal vitrectomy and panretinal laser coagulation in diabetic maculopathy treatment in patients with type 2 diabetes. The study included 150 patients, 150 eyes with diabetic retinopathy (DRP), diabetic maculopathy (DMP) and type 2 diabetes (T2D); 77 men and 73 women. DRP was in early, moderate or severe non-proliferative or proliferative stages. The duration of T2D ranged from 2,4 years to 32 years. 108 patients had a compensated T2D, 22 - subcompensated and 20 - decompensated one. These patients were distributed to two study groups: group 1 - 81 patients (81 eyes); group 2 - 69 patients (69 eyes). The patients underwent conventional ophthalmological examinations. The patients of study group 1 underwent closed subtotal vitrectomy combined with panretinal laser coagulation, group 2 - cataract phacoemulsification combined with closed subtotal vitrectomy and panretinal laser coagulation. It has been determined that cataract phacoemulsification combined with closed subtotal vitrectomy and panretinal laser coagulation is an effective method of treatment for patients with diabetic maculopathy, diabetic retinopathy and type 2 diabetes and it allowed reducing the incidence of diabetic macular edema to 10.77% and 26.15% respectively within the long-term period (6 months and 1 year). Performing cataract phacoemulsification surgery as a stage of the combined diabetic maculopathy treatment in patients with type 2 diabetes at a given study volume and follow-up time was a risk factor for lower resorption of diabetic macular edema in the early periods after the intervention.

Key words: diabetic maculopathy, cataract phacoemulsification, closed subtotal vitrectomy, panretinal laser coagulation.

In 2014, there were 422 million people with type 2 diabetes (T2D) - its prevalence amounted to 8.5% of the adult population. The prevalence of diabetes has been increasing steadily for the last 30 years and particularly high rates were observed in the countries with low-income and middle-income economies. According to the WHO (2018), diabetes +is an important cause of blindness, renal failure, lower limb amputations and other long-term negative effects that significantly affect the quality of life [1].

Diabetic retinopathy (DRP) is a common nonspecific vascular complication of diabetes characteristic for late stages of both type 1 diabetes (T1D) and type 2 diabetes (T2D). According to WHO data, DRP is among the main causes of hypovision and blindness and constitutes 1% for each case respectively. DRP constitutes 13% of the main causes of blindness in people aged over 50 [2]. There are data evidencing that patients with diabetes are 25 times more likely to become blind than the rest of the population [3].

Diabetic maculopathy (DMP) is one of the main causes of central vision impairment as well as visual field changes in patients with DRP and T2D. DMP manifests as diabetic macular edema (DME), which is its main symptom, as well as microaneurysms, intraretinal microvascular anomalies (IRMA), solid exudates, ischemia, and detachment of the posterior hyaloid membrane of the vitreous body in the macula [3, 4]. As a result of many years of research, it was determined that the risk of developing DME is higher in patients with T2D [5]. The 10 years' observation has shown that every patient with T2D treated by insulin injections had DME as well as 13.9% of patients who have been receiving other types of glucose-lowering therapy [3-7].

We have previously reported on the specific features of diabetic maculopathy in patients with type 2 diabetes [8].

Conventional methods of treatment of the DMP with DME are conservative, laser methods, intravitreal introduction of anti-VEGF drugs and glucocorticoids, as well as their combination.

Unfortunately, laser treatment methods for DME have limited capacity due to a retinal thickness in the macular region; this method is more effective in the early stages of DME.

A surgical treatment, namely various types of vitrectomy with endolaser coagulation of the retina or subsequent panretinal laser coagulation, as well as the removal of the posterior hyaloid membrane (PHM) and, if necessary, of the internal limiting membrane of the retina (ILM), and also combined with intravitreal injection of anti-VEGF drugs is used for more severe forms of DMP and DME which are resistant to conservative, laser, and intravitreal therapies [3, 9-12].

DRP and DMP are often combined with cataract. It is known that the most modern method of surgical treatment such as cataract phacoemulsification (PHACO) is a risk factor for the development of macular edema [13]. Macular edema can complicate the postoperative period even after performing of femtosecond laser-assisted PHACO [14]. Cataract phacoemulsification is considered to be a risk factor for DRP progression [15]. Nevertheless, vitreoretinal surgeons often prefer combined surgical intervention - subtotal closed virectomy (SCL) and panretinal laser coagulation (PRLC) combined with cataract phacoemulsification if DRP and DMP are accompanied by a cataract.

It is undoubtedly interesting how this combined treatment namely closed subtotal vitrectomy, PRLC combined with PHACO influences the clinical course of DMP and DME.

Purpose of the study - to study the possibilities and effectiveness of cataract phacoemulsification, closed subtotal vitrectomy and panretinal laser coagulation in diabetic maculopathy treatment in patients with type 2 diabetes.

Materials and methods

We have observed 150 patients, 150 eyes with DRP, DMP, and T2D; 77 men and 73 women. DRP was in early, moderate or severe non-proliferative or proliferative stages. The duration of T2D ranged from 2,4 years to 32 years. 108 patients had a compensated T2D, 22 - subcompensated and 20 - decompensated one. These patients were distributed to two study groups: group 1 - 81 patients (81 eyes); group 2 - 69 patients (69 eyes). Both study groups were statistically homogeneous by sex, age, level of compensation for T2D and DRP stage (p>0.05).

The patients of both study groups had conventional ophthalmological examinations, which included visometry, static perimetry with Humphrey, refractometry, tonometry, biomicroscopy, gonioscopy, ophthalmoscopy using aspheric lenses Volk Super / Field (NC USA) and Goldmann three-mirror contact lens (Volk USA). All the patients underwent spectral domain optical coherence tomography (OCT) on Optopoltechnology device, SOCT, Copernicus REVO (Retina 3D protocol, RetinaRaster) and OCT using Angio mode (RetinaAngio protocol). The presence of true (vascular) decorrelation signal in the preretinal sections of the vitreous body to identify the early processes of retinovitreal neovascularization, as well as the areas of capillary occlusion (ischemia) of the superficial and deep vascular plexus of the retina was determined. An improved algorithm was used to analyze the images of optical coherence tomography of the macular region of the retina in cases of diabetic macular edema [16]. The procedure of the fundus of the eye examination with a fundus camera taking photos in 7 standard fields of AirlieHouse modified ETDRS system of clinical signs was performed as well. Fluorescein angiography (FA) was performed on TOPCON TRS-NW7SF device according to indications (if early retinovitreal proliferation or neovascularization was suspected, which was not identified by ophthalmoscopy and by fundus of the eye photography, and also in cases when visual functions did not correspond to ophthalmoscopic changes in the macular region or to OCT results).

The severity level of DRP and DMP was identified according to the International Clinical Diabetic Retinopathy Disease Severity Scale of the American Academy of Ophthalmology (2002) [3].

The indications for closed subtotal vitrectomy were progressive reduction in visual acuity, central and paracentral visual fields changes, change in quality of vision as a result of partial hemophthalmos in central parts of the vitreous body reducing central vision (in case of early non-proliferative diabetic retinopathy (NPDR)); development of hemophthalmos, preretinal and subhyaloid hemorrhages, presence of tangential and axial tractions of the retina and threat of traction retinal detachment, as a result of fibrovascular tissue formation (in case of moderate, severe NPDR, PDR); vitreomacular traction syndrome due to taut posterior hyaloid development (in case of early, moderate NPDR); epimacular membrane formation or ILM changes (in case of early NPDR); macular edema resistant to conservative and laser therapy, as well as anti-VEGF therapy (at any DRP stage).

The indications for conducting closed subtotal vitrectomy in patients with decompensated diabetes was a progressive reduction in visual acuity with the threat or presence of traction retinal detachment on the only eye that could see.

Three-port closed subtotal vitrectomy 25+ was performed on the Constellation Vision System device (Alcon, USA) using the Constellation TOTALPLUS cassette combined 7500СРМ, 25+ caliber (Alcon, USA) in the patients of study group 1. The ports were made by 25-gauge trocars in the upper-temporal, uppernasal and lower-temporal quadrants. An irrigation cannula was inserted into the port in the lower-temporal quadrant using a balanced salt solution (BSS). Vitrectomy of central and peripheral layers of the vitreous body was performed with prior administration of triamcinolone acetonide for better visualization of the structures that were removed. An extrusion line was used to detach a posterior hyaloid membrane of the vitreous body; and posterior hyaloid and epiretinal membranes were removed with a vitreotome or vitreal forceps. Tangential and axial retinal tractions were removed as well. Vitrectomy of extreme peripheral retina was performed by the means of sclerocompression. Further, ILM 2.5-3.5 mm in diameter was removed in the macular region with a preliminary injection of Membrane Blue dye into the vitreous cavity for clear ILM visualization. Endolaser coagulation of the retina was performed with 25-gauge endolaser probe. Laser coagulation was performed with integrated endolaser PurePoint (Alcon, USA) with 25 Ga endolaser probe. Depending on the fundus of the eye tissues pigmentation, the parameters of laser radiation were selected until a medium-degree burn (23 degrees) appeared. The radiation parameters ranged from radiation power 100-200 mW, impulse duration 100-200 milliseconds, interval 100-150 milliseconds. Subsequently, the fluid was replaced by sterile air. 18% gas-air mixture C3F8 was injected into the vitreous cavity. The trocars were removed and the ports were sealed.

The patients of group 2 underwent cataract phacoemulsification combined with closed subtotal vitrectomy with PRLC stage. The cataract phacoemulsification was performed according to the standard procedure on Constellation Vision System device (Alcon, USA) using Constellation TOTALPLUS cassette of combined 7500СРМ, 25+ caliber (Alcon, USA) through 2.65 or 2.2 mm incisions. The nucleus disassembly was performed with ultrasound tip and phaco-chopper. The ultrasound parameters were selected depending on nucleus density, which was determined according to the nucleus density classification by L. Buratto. The phaco needles of Kelman ABC 0.9 mm model were used in Burst mode. After removing pre-cortical mass residues and posterior capsule polishing, Alcon intraocular lens model SA60AT was implanted taking into account its hydrophobic properties.

The effect of cataract phacoemulsification combined with closed subtotal vitrectomy and PRLC compared with only closed subtotal vitrectomy and PRLC on the clinical progress and DMP and DME regression was studied. Complications and functional treatment results were studied as well.

While conducting an analysis to provide quantitative data, mean value (M) and standard deviation (±SD) were reported in the tables. The frequency indicator (P, %) and standard error (±m) were reported for qualitative data. The difference of mean values in two samples was evaluated with Student t-test (in case of normal distribution) or with Wilcoxon test (in the case when distribution deviated from normal values). The method of comparison of paired samples was used to analyze the dynamics of indicators. Fisher's exact test was used to compare qualitative signs. The critical level of significance was assumed to be 0.05.

The follow-up time is 1 year.

Results and discussion

The maximum corrected visual acuity before surgery in study group 1 ranged from 0.07 to 0.5 and averaged 0.2±0.08. The central and paracentral relative or absolute scotomas were detected in 34 eyes (41.97%). All the patients had the manifestations of DMP - microaneurysms and microhemorrhages in the macular region, IRMA, deposits of solid exudates, and DME of different degrees of manifestation with cystic cavities. The mean retinal thickness ranged from 320 pm to 805 pm and averaged 471.5±45.0 pm. The average volume of the macular region of the retina before surgery in study group 1 was 13.7±1.6 mm³.

The maximum corrected visual acuity before the surgery in study group 2 varied from 0.02 to 0.4 and averaged 0.15±0.05. The central and paracentral relative or absolute scotomas were detected in 29 eyes (42.03 %). All the eyes had the signs of DMP - microaneurysms and microhemorrhages in macular region, IRMA, deposits of solid exudates, and DME of different degrees of manifestation with cystic cavities. The mean retinal thickness ranged from 300 pm to 740 pm and averaged 462.0±28.0 pm. The average volume of the macular region of the retina before surgery in study group 2 was 13.1±1.3 mm³.

The surgeries were fully performed in both study group 1 and study group 2.

When analyzing the intraoperative complications, it was found that their nature, frequency, and duration in both study group 1 and 2 were statistically comparable. After removal of the internal limiting membrane of the retina in 5 eyes (6.17%) and 4 eyes (5.8%) in study groups 1 and 2 respectively some microhemorrhages developed and dissolved within 1-2 days on their own. By the end of the surgery partial hemophthalmos has developed in 4 eyes (4.94%) in group 1 and in 4 eyes (5.8%) in group 2. In all cases, hemophthalmos regressed without additional treatment within 2-3 days.

Such early postoperative complications as hyphema and partial hemophthalmos, inflammatory complications and transient hypertension (p>0.05) were noted in both study groups.

Table 1 shows retinal thickness (pm) in the macular region in both study groups before and after 1, 3, 6 months after surgical treatment (M ± SD)

Table 1

RETINAL THICKNESS (MM) IN THE MACULAR REGION BEFORE AND AFTER 1, 3, 6 MONTHS AFTER A CLOSED SUBTOTAL VITRECTOMY AND PRLC (GROUP 1) AND PHACO COMBINED WITH CLOSED SUBTOTAL VITRECTOMY AND PRLC (GROUP 2) (M ± SD)

* - statistically significant difference of data (p <0.05) compared to the data before surgery.

As shown in Table 1 vitrectomy with PRLC (group 1) and cataract phacoemulsification combined with vitrectomy and PRLC (group 2) allowed for statistically significant (p<0.05) reduction of retinal thickness in the macular region after 1, 3 months compared to the preoperative one. However, it should be noted that although the average value of retinal thickness in the macular region 1 month after surgery in both study groups 1 and 2 has been decreasing significantly in terms of statistics, but it was significantly higher in group 2, where PHACO was performed with closed subtotal vitrectomy and PRLC; and it was due to the intervention technique specifics. 6 months and 1 year after the intervention, retinal thickness increase was observed in both study group 1 and 2, and it was due to DME recurrence. It should be noted that after 6 months and 1 year the thickness of the macular region was statistically significantly lower than before the surgery in both study groups.

Table 2 presents the dynamics of the retinal volume in macular region (mm³) in study groups 1 and 2 before and after 1, 3, 6 months after surgical treatment (M±SD).

Table 2

DYNAMICS OF RETINAL VOLUME IN THE MACULAR REGION (MM³) BEFORE AND AFTER 1, 3, 6 MONTHS AFTER CLOSED SUBTOTAL VITRECTOMY AND PRLC (GROUP 1) AND PHACO COMBINED WITH CLOSED SUBTOTAL VITRECTOMY AND PRLC (GROUP 2) (M±SD)

* - statistically significant difference of data (p <0.05) compared to the data before surgery.

As presented in Table 2, vitrectomy with PRLC (group 1) and cataract phacoemulsification combined with vitrectomy and PRLC (group 2) allowed to reduce the retinal volume in the macular region in 1 and 3 months after surgery (p<0.05). 6 months and 1 year after the intervention, increase of retinal thickness in the macular region was observed in both study groups, and it was due to DME recurrence. The macular retinal thickness and volume of macular region was manifestations of DMP in 1, 3, 6 months and 1 year after the intervention. It is noteworthy that in study group 1 the DME frequency after 1 month has decreased to 14.8%, and in group 2 - only to 31.88%, after 3 months to 14.8% and 21.74% respectively. retina subtotal macular region

Table 3

FREQUENCY OF DME AND OTHER MANIFESTATIONS OF DMP (MICROHEMORRHAGES, SOLID EXUDATES) IN 1, 3, 6 MONTHS AND 1 YEAR AFTER CLOSED SUBTOTAL VITRECTOMY AND PRLC (GROUP 1) AND PHACO COMBINED WITH CLOSED SUBTOTAL VITRECTOMY AND PRLC (GROUP 2)

* - statistically significant difference of data (p <0.01) compared to the data before surgery.

As presented in Table 3, combined surgical treatment, including closed subtotal vitrectomy and PRLC (group 1) and PHACO, closed subtotal vitrectomy and PRLC (group 2) allowed to reduce the statistically significant frequency of DME and other statistically significantly lower than before surgery and was not statistically different in both study groups.

Table 3 presents the frequency of DME and other manifestations of DMP (microhemorrhages, solid exudates) in 1, 3, 6 months and 1 year after closed subtotal vitrectomy and PRLC (group 1) and PHACO combined with closed subtotal vitrectomy and PRLC (group 2).

In our opinion, this was due to the specifics of cataract phacoemulsification technique. Even masterly performed PHACO lengthens the time of surgical intervention, causes intraocular pressure variations and may amplify the inflammatory response in the postoperative period. One should not exclude the possibility that these factors, as well as ultrasound effects and an increase in fluid volume that circulates in the eye during PHACO, have a negative effect on the macular region of the retina and can contribute to its swelling, and perhaps even amplify it in the early stages after surgery.

Conclusions

Cataract phacoemulsification combined with closed subtotal vitrectomy and panretinal laser coagulation is an effective treatment for patients with DMP, DRP, and T2D, which allowed to reduce the frequency of DME to 10.77% and 26.15% respectively in the long-term period (6 months and 1 year).

PHACO as a stage of the combined treatment of DMP in patients with T2D with a given study volume and follow-up time was a risk factor for lower DME resorption in the early periods after the intervention.

To improve the effectiveness of both DMP and DME treatment in patients with DRP and T2D one should study their new aspects of etiology, pathogenesis and risk factors, both local - the organ of vision and the whole body.

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