Lisätietoa aiheesta

Landmark trials: Näkökentän puutoksen ja progression kriteerit

Lisätietoa aiheesta
28.3.2023
Käypä hoito -työryhmä Glaukooma

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 different methods for detecting glaucomatous visual field progression. Invest Ophthalmol Vis Sci 2003;44:3873-9 »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
AGISCNTGSEMGTCIGTSOHTS
Advanced Glaucoma Intervention StudyCollaborative Normal Tension Glaucoma StudyEarly Manifest GlaucomaCollaborative Initial Glaucoma TreatmentOcular Hypertension Treatment Study
Keskuksia112411422
Potilaita (silmiä)591 (789 -> 586)145->1402556071637
ProtokollaATT / TAT*Hoito / ei-hoitoaHoito / ei-hoitoaLääke / leikkaushoitoHoito / ei-hoitoa
DiagnoosiPOAGLTGPOAG, LTG, ExfPOAG, Exf, PigmOHT
Seuranta-aika (vuotta)7 vuotta5 vuotta4 vuotta5 vuotta
Status7 julkaisua5 julkaisuaKeskenKeskenKesken
AineistoKlinikka-aineistoKlinikka-aineistoVäestöpohjainen (85 %)Klinikka-aineistoKlinikka-aineisto
Näkökentät
OhjelmaHumphrey (H) 24-2H30-22 tai Octopus 32H30-2H24-2H30-2
Lähtötaso alussa (kenttää)4 kenttää3 kenttää4 kenttää2 kenttää3 kenttää
LuotettavuuskriteeritPisteytys (Scoring): 0–7"Tiukennetut""Tavalliset"Pisteytys (Scoring): 0 - 6"Tavalliset" > +5D ->pl,
mu < 3mm -> laaj.
Tutkimusten väli6 kk3kk -> 6kk3 kk3kk -> 6 kk6 kk
PogressionmääritelmäYksittäisten pisteidenYksittäisten pisteidenPattern deviationTotal deviationVisual Field reading
poikkeamatpoikkeamat plot: Change probabilityplot: P-arvotCenter
Pisteytys (Scoring)0–20EiEi0–208 -> 0–20Ei
Patololginen määritelmäScoren mukaan3 määritelmääGHTGHTCPSD < 0,5 or GHT
ProgressioScoren2 vier. pisteenP < 0,5 % muutoksiaScoren2 indipendent senior
muutos vähintään 3 yksikköämuutos yli 10 dBvähintään 3muutos vähintään 2 yksikköäreaders, masked
Prog:n varmennus2 kenttää 4–6 kenttää2 kenttää2 kenttää2 -> 3
Papilla Ei kuviaVuoden välein6 kk:n väleinEi kuvia12 kk:n välein
(90 %:lla patol. alussa)
MuutaNK-progression kriteerejä tiukennettiin –94 «Schulzer M. Errors in the diagnosis of visual field progression in normal-tension glaucoma. Ophthalmology 1994;101:1589-94; discussion 1595 »7Kaihiluokitus LOCSillaHRQOLNK-progression kriteerejä tiukennettiin –98 «The Glaucoma Laser Trial (GLT): 6. Treatment group differences in visual field changes. Glaucoma Laser Trial Research Group. Am J Ophthalmol 1995;120:10-22 »12
384 kys./ 45 min
HRT ja SWAP
7 keskusta, 98 alk.
«Ederer F, Gaasterland DE, Sullivan EK ym. The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients. Control Clin Trials 1994;15:299-3»1, «The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol 2000;130:429-40 »2, «The Advanced Glaucoma Intervention Study (AGIS): 4. Comparison of treatment outcomes within race. Seven-year results. Ophthalmology 1998;105:1146-64 »3 «Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Collaborative Normal-Tension Glaucoma St»4, «The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol 1998;126:498-505 »5, «Anderson DR, Drance SM, Schulzer M ym. Natural history of normal-tension glaucoma. Ophthalmology 2001;108:247-53 »6, «Schulzer M. Errors in the diagnosis of visual field progression in normal-tension glaucoma. Ophthalmology 1994;101:1589-94; discussion 1595 »7 «Leske MC, Heijl A, Hyman L ym. Early Manifest Glaucoma Trial: design and baseline data. Ophthalmology 1999;106:2144-53 »8 «Musch DC, Lichter PR, Guire KE ym. The Collaborative Initial Glaucoma Treatment Study: study design, methods, and baseline characteristics of enrolled patients. Ophthalmology 1999;106:653-62 »9 «Gordon MO, Kass MA. The Ocular Hypertension Treatment Study: design and baseline description of the participants. Arch Ophthalmol 1999;117:573-83 »10, «Keltner JL, Johnson CA, Quigg JM ym. Confirmation of visual field abnormalities in the Ocular Hypertension Treatment Study. Ocular Hypertension Treatment Study Group. Arch Ophthalmol 2000;118:1187-94 »11

Kirjallisuutta

  1. Ederer F, Gaasterland DE, Sullivan EK ym. The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients. Control Clin Trials 1994;15:299-325 «PMID: 7956270»PubMed
  2. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol 2000;130:429-40 «PMID: 11024415»PubMed
  3. The Advanced Glaucoma Intervention Study (AGIS): 4. Comparison of treatment outcomes within race. Seven-year results. Ophthalmology 1998;105:1146-64 «PMID: 9663215»PubMed
  4. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol 1998;126:487-97 «PMID: 9780093»PubMed
  5. The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol 1998;126:498-505 «PMID: 9780094»PubMed
  6. Anderson DR, Drance SM, Schulzer M ym. Natural history of normal-tension glaucoma. Ophthalmology 2001;108:247-53 «PMID: 11158794»PubMed
  7. Schulzer M. Errors in the diagnosis of visual field progression in normal-tension glaucoma. Ophthalmology 1994;101:1589-94; discussion 1595 «PMID: 8090461»PubMed
  8. Leske MC, Heijl A, Hyman L ym. Early Manifest Glaucoma Trial: design and baseline data. Ophthalmology 1999;106:2144-53 «PMID: 10571351»PubMed
  9. Musch DC, Lichter PR, Guire KE ym. The Collaborative Initial Glaucoma Treatment Study: study design, methods, and baseline characteristics of enrolled patients. Ophthalmology 1999;106:653-62 «PMID: 10201583»PubMed
  10. Gordon MO, Kass MA. The Ocular Hypertension Treatment Study: design and baseline description of the participants. Arch Ophthalmol 1999;117:573-83 «PMID: 10326953»PubMed
  11. Keltner JL, Johnson CA, Quigg JM ym. Confirmation of visual field abnormalities in the Ocular Hypertension Treatment Study. Ocular Hypertension Treatment Study Group. Arch Ophthalmol 2000;118:1187-94 «PMID: 10980763»PubMed
  12. The Glaucoma Laser Trial (GLT): 6. Treatment group differences in visual field changes. Glaucoma Laser Trial Research Group. Am J Ophthalmol 1995;120:10-22 «PMID: 7611312»PubMed
  13. Vesti E, Johnson CA, Chauhan BC. Comparison of different methods for detecting glaucomatous visual field progression. Invest Ophthalmol Vis Sci 2003;44:3873-9 «PMID: 12939303»PubMed