Takaisin Tulosta

Landmark trials: Näkökentän puutoksen ja progression kriteerit

Lisätietoa aiheesta
Käypä hoito -työryhmä Glaukooma
28.3.2023

The performance characteristics of seven methods for analyzing glaucomatous visual field progression were evaluated using a combination of real patient data and computer simulation techniques «Vesti E, Johnson CA, Chauhan BC. Comparison of dif...»13. The initial and final visual field results, separated by 7 years and measured with the full-threshold 30-2 program of the Humphrey Field Analyzer of 76 patients with open-angle glaucoma were used. A computer simulation program generated 14 interim semiannual visual fields under conditions of high, moderate, and no variability. Progression was analyzed using the methods of the Advanced Glaucoma Intervention Study (AGIS), the Collaborative Initial Glaucoma Treatment Study (CIGTS), three criteria based on the Glaucoma Change Probability (GCP) analysis, and two criteria based on point-wise linear regression analysis (PLRA).

Under the no-variability condition, progression rates were 18% for the AGIS, 36% for CIGTS, 47% to 62% for the three GCP methods, and 72% and 84% for the two PLRA methods. Progression rates increased with greater variability with the three GCP methods and decreased with all other methods. The time to detect confirmed progression was longest for the PLRA methods and shortest for the CIGTS and GCP methods. Under the moderate-variability condition, all methods yielded high specificity. The AGIS, CIGTS, and one of the GCP and PLRA methods were relatively resistant to high variability and maintained high specificities.

The ideal method for analyzing visual field change should be sensitive, detect progression with few examinations, maintain high specificity, and be resistant to fluctuation. The results showed that none of the methods investigated could achieve all these attributes. Methods that yielded a high number of progressing cases were often less specific and were influenced by fluctuation. In contrast, those methods that yielded high specificity often required very long follow-up times. Furthermore, in agreement with a previous study, there was poor concordance among the methods with respect to the patients identified as progressing.

Taulukko 1. Näkökentän puutoksen ja progression kriteerit.
Valmiit tutkimukset Keskeneräiset tutkimukset
AGIS CNTGS EMGT CIGTS OHTS
Advanced Glaucoma Intervention Study Collaborative Normal Tension Glaucoma Study Early Manifest Glaucoma Collaborative Initial Glaucoma Treatment Ocular Hypertension Treatment Study
Keskuksia 11 24 1 14 22
Potilaita (silmiä) 591 (789 -> 586) 145->140 255 607 1637
Protokolla ATT / TAT* Hoito / ei-hoitoa Hoito / ei-hoitoa Lääke / leikkaushoito Hoito / ei-hoitoa
Diagnoosi POAG LTG POAG, LTG, Exf POAG, Exf, Pigm OHT
Seuranta-aika (vuotta) 7 vuotta 5 vuotta 4 vuotta 5 vuotta
Status 7 julkaisua 5 julkaisua Kesken Kesken Kesken
Aineisto Klinikka-aineisto Klinikka-aineisto Väestöpohjainen (85 %) Klinikka-aineisto Klinikka-aineisto
Näkökentät
Ohjelma Humphrey (H) 24-2 H30-22 tai Octopus 32 H30-2 H24-2 H30-2
Lähtötaso alussa (kenttää) 4 kenttää 3 kenttää 4 kenttää 2 kenttää 3 kenttää
Luotettavuuskriteerit Pisteytys (Scoring): 0–7 "Tiukennetut" "Tavalliset" Pisteytys (Scoring): 0 - 6 "Tavalliset" > +5D ->pl,
mu < 3mm -> laaj.
Tutkimusten väli 6 kk 3kk -> 6kk 3 kk 3kk -> 6 kk 6 kk
Pogressionmääritelmä Yksittäisten pisteiden Yksittäisten pisteiden Pattern deviation Total deviation Visual Field reading
poikkeamat poikkeamat plot: Change probability plot: P-arvot Center
Pisteytys (Scoring) 0–20 Ei Ei 0–208 -> 0–20 Ei
Patololginen määritelmä Scoren mukaan 3 määritelmää GHT GHT CPSD < 0,5 or GHT
Progressio Scoren 2 vier. pisteen P < 0,5 % muutoksia Scoren 2 indipendent senior
muutos vähintään 3 yksikköä muutos yli 10 dB vähintään 3 muutos vähintään 2 yksikköä readers, masked
Prog:n varmennus 2 kenttää 4–6 kenttää 2 kenttää 2 kenttää 2 -> 3
Papilla Ei kuvia Vuoden välein 6 kk:n välein Ei kuvia 12 kk:n välein
(90 %:lla patol. alussa)
Muuta NK-progression kriteerejä tiukennettiin –94 «Schulzer M. Errors in the diagnosis of visual fiel...»7 Kaihiluokitus LOCSilla HRQOL NK-progression kriteerejä tiukennettiin –98 «The Glaucoma Laser Trial (GLT): 6. Treatment group...»12
384 kys./ 45 min
HRT ja SWAP
7 keskusta, 98 alk.
«Ederer F, Gaasterland DE, Sullivan EK ym. The Adva...»1, «The Advanced Glaucoma Intervention Study (AGIS): 7...»2, «The Advanced Glaucoma Intervention Study (AGIS): 4...»3 «Comparison of glaucomatous progression between unt...»4, «The effectiveness of intraocular pressure reductio...»5, «Anderson DR, Drance SM, Schulzer M ym. Natural his...»6, «Schulzer M. Errors in the diagnosis of visual fiel...»7 «Leske MC, Heijl A, Hyman L ym. Early Manifest Glau...»8 «Musch DC, Lichter PR, Guire KE ym. The Collaborati...»9 «Gordon MO, Kass MA. The Ocular Hypertension Treatm...»10, «Keltner JL, Johnson CA, Quigg JM ym. Confirmation ...»11

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