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Morfološke karakteristike makule kao prognostički faktor poboljšanja vidne oštrine u terapiji pacijenata obolelih od dijabetesnog makularnog edema / Morphological characteristics of the macula as a prognostic factor of visual acuity improvement in the treatment of patients with diabetic macular edema

<p>Cilj ovog istraživanja je da se ispita uticaj centralne debljine makularne regije (CMT) i prisustva subretinalne tečnosti na vidnu o&scaron;trinu (VA) kod pacijenata obolelih od dijabetesnog makularnog edema, kao i uticaj očuvanosti kontinuiteta spoja spolja&scaron;njeg i unutra&scaron;njeg segmenta fotoreceptora (IS/OS &ndash; kompleks) i spolja&scaron;nje granične membrane (ELM) kao prognostičkih faktora u pobolj&scaron;anju vidne o&scaron;trine nakon primenjene terapije kod pacijenata obolelih od dijabetesnog makularnog edema (DME). Materijal i metode: u ovu retrospektivno prospektivnu kliničku studiju nasumično je uključeno 100 pacijenata koji su podeljeni u dve grupe. Grupu A &ndash; prospektivni deo studije je činilo 50 pacijenata (50 očiju) kod kojih je dijagnostikovan dijabetesni makularni edem i kod kojih je inidikovana primena terapije, laserftotkogaulacije i/ili anti-VEGF terapije (bevacizumab). Grupu B &ndash; retrospektivnu grupu je činilo 50 pacijenata (58 očiju) koji su prethodno lečeni od dijabetesnog makularnog edema primenom laserfotokoagulacije i/ili anti-VEGF terapije (bevacizumab). Nakon kompletnog oftalmolo&scaron;kog pregleda koji se sastojao od određivanja vidne o&scaron;trine (optotipima po Snellenu), biomikroskopije, merenja intraokularnog pritiska i pregleda očnog dna &ndash; fundusa primenom panfundoskopa izvr&scaron;ena je optička koherentna tomografija u svih pacijenata (primenom aparata Stratus&reg; OCT, Carl Zeiss, Meditec i Copercnicus&reg; Optopol). Analiza OCT snimka, je obuhvatila određivanje centralne debljine makule (CMT), prisustva subretinalne tečnosti kao i procenu stanja očuvanosti kontinuiteta spoja spolja&scaron;enjeg i unutra&scaron;njeg segmenta fotoreceptora (IS/OS kompleks) i očuvanost kontinuiteta spolja&scaron;nje granične membrane (ELM). CMT je izračunat primenom softvera OCT aparata i izražen kao srednja vrednost za svih 9 ETDRS polja. Prisutvno subretinalne tečnosti je klasifikovano kao pozitivno ukoliko je identifikovano makar u jednom preseku OCT tomograma .Očuvanost kontinuiteta IS/OS kompleksa i ELM je analizirana u svakom pojedinačnom snimku i podeljena u 3 kategorije. Prva &ndash; ukoliko je očuvano u svim presecima, druga &ndash; ukoliko je očuvano samo u pojedinim presecima i treća &ndash; ukoliko se IS/OS kompleks i ELM nisu mogli identifikovati na nalazu OCT tomograma. Rezultati ukazuju da prisustvo subretinalne tečnosti pre primenjene terapije nema statistički značajnog uticaja na pobolj&scaron;anje vidne o&scaron;trine nakon primenjene terapije u pacijenata grupe A (pA=0,915), a statistička značajnost nije potvrđena ni kod pacijenata koji su prethodno tretirani od DME &ndash; grupa B (pB=0,772). Srednja vrednosti CMT i VA u pacijaneta grupe A iznosila je 474&mu;m&plusmn;140,67&mu;m odnosno 0.25&plusmn;0.20. Nakon primenjene terapije srednja vrednost vidnih o&scaron;trina iznosila je 0.41&plusmn;0.25, dok su vrednosti srednje vrednosti CMT iznosile 343.68&mu;m&plusmn;99.03&mu;m. Potvrđeno je statistički značajno pobolj&scaron;anje vidne o&scaron;trine nakon primenjene terapije (pVA=0,0001) i statistički značajno smanjenje centralne debljine makule (pCMT=0,0001). Korelacija VA sa vrednostima CMT pre primenjene terapije pokazuje statističku značajnost sa negativnom korelacijom (r=-0,391; p=0,005) dok se nakon primenjene terapije ne uočava statistički značajna korelacija (r=-0,047; p=0,746). Analizom vrednosti CMT pre primenjene terapije sa vrednostima VA nakon terapije se uočava statistički značajna negativna korelacija, odnosno veće vrednosti CMT pre primenjene terapije ograničavaju pobolj&scaron;anje vidne o&scaron;trine nakon primenjene terapije (r=-0,393; p=0,005). Evaluacija OCT tomograma, pre primenjene terapije, u pacijenata grupe A utvrđen je u potpunosti očuvan kontinuitet IS/OS kompleksa i ELM u svim presecima u 23 odnosno 27 očiju, u pojedinim presecima u 18 odnosno 16 očiju, i nije mogao biti identifikovan u 9 odnosno 7 očiju. U pacijenata grupe A nakon primenjene terapije uočava se statistički značajno pobolj&scaron;anje vrednosti VA u zavisnosti od očuvanosti kontinuiteta IS/OS kompleksa (F=5,550, p=0,007) i ELM (F=5,428, p=0,008). Univarijantna odnosno multivarjiantna analiza podataka za granične vrednosti vidnih o&scaron;trina od 0,1 i koraka pobolj&scaron;anja od 0,1 ukazuje na statističku značajnost prediktora IS/OS kompleksa (p=0,012 i p=0,032) i ELM (p=0,003 i p=0,018) u pobolj&scaron;anju vrednosti vidnih o&scaron;trina nakon primenjene terapije. Pacijenti sa očuvanim kontinuitetom IS/OS kompelsa u svim presecima imaju 9,5 puta (OR=9,500 ) veću &scaron;ansu za pobolj&scaron;anje VA nakon primenjene terapije u odnosu na pacijente gde kontinuitet IS/OS kompleksa nije uočljiv. Pacijenti sa očuvanim kontinuitetom IS/OS kompleksa u pojedinim presecima imaju 7 puta veću &scaron;ansu (OR=7,000) za pobolj&scaron;anje vidne o&scaron;trine nakon terapije u poređenju sa onima kod kojih IS/OS nije uočljiv. Pacijenti sa očuvanim kontinuitetom ELM u svim presecima imaju 34,5 puta (OR=34,500 ) veću &scaron;ansu za pobolj&scaron;anje vidne o&scaron;trine u odnosu na pacijente gde ELM nije uočljiv. Pacijenti sa očuvanim kontinuitetom ELM u pojedinim presecima imaju 18 puta veću &scaron;ansu (OR=18,000) za pobolj&scaron;anje VA nakon terapije u odnosu na one kod kojih ELM nije uočljiv. Pored statistički značajnog uticaja očuvanosti kontinuiteta IS/OS kompleksa i ELM na pobolj&scaron;anje vrednosti vidnih o&scaron;trina nakon primenjene terapije, uočava se i pozitvna korelacija između vidnih o&scaron;trina pre i nakon terapije (r=0,869; p=0,0001). U pacijenata grupe B srednja vrednost CMT odnosno VA iznosila je 253,72&mu;m&plusmn;75,27&mu;m odnosno 0,68&plusmn;0,29. Postoji statistički značajna razlika u vrednostima VA u odnosu na očuvanost kontinuiteta IS/OS kompleksa (F=107,913, p=0,0001) i ELM (F=25,619, p=0,0001). Poređenjem vrednosti parametara za obe posmatrane grupe uočava se statistički značajna razlika u vrednostima CMT koje su bile manje u grupi B (t=5,355, p=0,0001) i srednjim vrednostima VA ( t=5,137, p=0,0001) koje su bile veće u grupi B. Analizom očuvanosti kontinuiteta IS/OS kompleksa (&chi;2=0,119, p=0,730) i ELM (&chi;2=2,957, p=0,085) ne uočava se statistički značajna razlika. Zaključak: Odnos vidnih o&scaron;trina sa centralnom debljinom makule prikazuje različite vrednosti vidnih o&scaron;trina za iste vrednosti centralne debljine makule. Značajan uticaj na vidnu o&scaron;trinu pacijenata obolelih od DME ima očuvanost integriteta spolja&scaron;nje granične membrane (ELM) i spoja unutra&scaron;njeg i spolja&scaron;njeg segmenta fotoreceptora (IS/OS kompleks) evaluiranih na osnovu OCT snimka &ndash; tomograma. Očuvanost integriteta ELM i IS/OS kompleksa u svim presecima na OCT tomogramu pre primenjene terapije u pacijenta sa DME se mogu smatrati pozitivnim prognostičkim faktorom u pobolj&scaron;anju vidne o&scaron;trine nakon primenjene terapije. U pacijenata kod kojih je kontinuitet ELM i IS/OS kompleksa očuvan u svim pravcima vrednost CMT pre primenjene terapije nema uticaj na pobolj&scaron;anje vidne funkcije nakon terapije. Integritet IS/OS kompleksa i ELM ima pozitivnu korelaciju sa vidnom o&scaron;trinom bez obzira na vrstu primenjene terapije, anti-VEGF odnosno laserfotokoagulacije. Prisustvo subretinalne tečnosti ne utiče na vidnu o&scaron;trinu pacijenata obolelih od DME. Vrednosti VA pre terapije utiču na pobolj&scaron;anje vidne o&scaron;trine nakon terapije.</p> / <p>The aim of this study was to investigate the influence of the central macular thickness (CMT) and the presence of sub retinal fluid on visual acuity (VA) in patients with diabetic macular edema, as well as the impact of preservation and continuity of the photoreceptor inner/outer segment junction (IS / OS - complex ) and external limiting membrane (ELM) as a prognostic factor in improving visual acuity after the applied therapy in patients with diabetic macular edema (DME). Materials and Methods: this retrospective - prospective randomized clinical study included 100 patients who were divided into two groups. Group A - a prospective part of the study, consisted of 50 patients (50 eyes), with the diagnosis of diabetic macular edema in which laser photocoagulation and / or anti-VEGF therapy (bevacizumab) was indicated. Group B - retrospective group, consisted of 50 patients (58 eyes), who were previously treated for diabetic macular edema either with laser photocoagulation and / or anti-VEGF therapy (bevacizumab). After complete ophthalmologic examination, which consisted of the determination of visual acuity (measured with Snellen charts), biomicroscopy, intraocular pressure measurement and inspection of the fundus, optical coherence tomography was performed in all patients (using the Stratus&reg; OCT, Carl Zeiss Meditec and Copercnicus&reg; Optopol). Analysis of OCT image, included the determination of the central macular thickness (CMT), presence of sub retinal fluid, as well as an assessment of the preservation of the continuity of the photoreceptor inner/outer segment junction (IS/OS - complex) and external limiting membrane (ELM). CMT is calculated using software of the OCT apparatus and expressed as the mean value for all 9 ETDRS fields. Presence of sub retinal fluid is classified as positive if it is identified in at least one cross-section of OCT tomogram. Preserved continuity of IS / OS complex and ELM is analyzed in each individual OCT cross-section image and divided into 3 categories. First - if it is preserved in all cross sections images, the second - if it is preserved only in certain sections and the third - if the IS / OS complex and ELM were not able to identify in OCT tomograms. The results indicate that the presence of sub retinal fluid before the applied therapy has no statistically significant effect on improving visual acuity after the applied therapy in patients of group A (pA = 0.915), and statistical significance was not also confirmed in any of the patients who were previously treated by DME - Group B (pB = 0.772). Mean CMT and VA values of patients in group A was 474&mu;m &plusmn; 140,67&mu;m and 0.25 &plusmn; 0.20. After receiving therapy mean visual acuity was 0.41 &plusmn; 0.25, while the value of the mean CMT was 343.68&mu;m&plusmn; 99.03&mu;m. Significant improvement in visual acuity was achieved after the treatment in group A (pVA = 0.0001) together with statistically significant reduction in central macular thickness (pCMT = 0.0001). Correlation of VA with the values of CMT before applied therapy shows statistically significant negative correlation (r = -0.391; p = 0.005), while after the applied therapy statistical significance was not observed (r = -0.047; p = 0.746). Analyzing the values of CMT before the applied therapy with the values of VA after the treatment statistically significant negative correlation was observed, higher values of CMT before the applied therapy restrict visual acuity improvement after the applied therapy (r = -0.393; p = 0.005). Analyzing OCT tomograms in the patients in group A, before the applied therapy, fully preserved continuity of IS/OS complex and ELM in all the sections was found in 23 and 27 of the eyes, in certain sections in 18 and 16 of the eyes, and could not be identified in 9 and 7 eyes. Statistically significant improvement in VA, after the applied therapy, in patients in group A is observed, depending on the preservation of continuity of IS/OS complex (F = 5.550, p = 0.007) and ELM (F = 5.428, p = 0.008). Univariate and multivariate analysis with cut off VA value of 0.1 and step improvements of 0.1 points to statistically significant predictor of IS/OS complex (p = 0.012 and p = 0.032) and ELM (p = 0.003 and p = 0.018) in improving the VA after the applied therapy. Patients with preserved continuity of IS/OS complex in all sections are 9.5 times (OR = 9.500) more likely to improve the VA after receiving therapy compared to patients where continuity of IS/OS complex is not noticeable. Patients with preserved continuity of IS/OS complex in the some sections are 7 times more likely (OR = 7.000) for the improvement of visual acuity after treatment compared to those in which the IS/OS is not detectable. Patients with preserved continuity of ELM in all sections are 34.5 times (OR = 34,500) a greater chance to improve visual acuity compared to patients where ELM is not apparent. Patients with preserved continuity of ELM in the some sections are 18 times more likely (OR = 18,000) to improve the VA after treatment compared to those in which the ELM is not apparent. In addition to statistically significant impact of preservation of continuity of IS/OS complex and ELM for VA improvement after the treatment, statistically significant positive correlation between visual acuity before and after treatment (r = 0.869; p = 0.0001) was observed. In Group B patients, the mean CMT and VA value was 253,72&mu;m&plusmn;75,268&mu;m and 0.68 &plusmn; 0.29. There is a statistically significant difference in the VA values compared to the preservation of continuity of IS/OS complex (F = 107.913, p = 0.0001) and ELM (F = 25.619, p = 0.0001). Comparing the values of parameters for both groups, statistically significant difference in CMT values and mean VA was observed. CMT values were lower (t = 5.355, p = 0.0001) while VA values were higher (t = 5.137, p = 0.0001), in group B. The analysis of preservation of continuity of IS/OS complex (&chi;2 = 0.119, p = 0.730) and ELM (&chi;2 = 2.957, p = 0.085) did not show a statistically significant difference. Conclusion: The relationship of visual acuity with central macular thickness shows the different levels of visual acuity for the same value of the central macular thickness. A significant impact on VA in patients with DME has maintained integrity of the external limiting membrane (ELM) and the photoreceptors inner/outer segments junction (IS/OS complex) evaluated on the basis of OCT - tomograms. Preservation of the integrity of the ELM and IS/OS complex in all sections of the OCT tomogram before applied therapy in patients with DME can be considered a positive prognostic factor in improving visual acuity after receiving therapy. In patients with preserved continuity of ELM and IS/OS complex in all sections before applied therapy the CMT value has no effect on the improvement of visual function after treatment. Regardless of the type of applied therapy, anti-VEGF and/or laser photocoagulation preserved integrity of IS/OS complex and ELM has a positive correlation with visual acuity. The presence of sub retinal fluid does not affect the visual acuity in patients with DME. The values of VA before treatment influence the improvement of visual acuity after treatment.</p>

Identiferoai:union.ndltd.org:uns.ac.rs/oai:CRISUNS:(BISIS)101090
Date26 September 2016
CreatorsDžinić Vladislav
ContributorsBabić Nikola, Oros Ana, Zlatanović Gordana, Vukosavljević Miroslav, Čanadanović Vladimir, Grković Desanka
PublisherUniverzitet u Novom Sadu, Medicinski fakultet u Novom Sadu, University of Novi Sad, Faculty of Medicine at Novi Sad
Source SetsUniversity of Novi Sad
LanguageSerbian
Detected LanguageUnknown
TypePhD thesis

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