Dataset Information

Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial.

ABSTRACT:

Background/aims

OASIS is a Phase IIIb trial (NCT01429441) assessing long-term outcomes in subjects with symptomatic vitreomacular adhesion (VMA). The purpose of this study is to report on the frequency, severity, location and time course of ellipsoid zone (EZ) alterations in ocriplasmin-treated and sham control eyes in the OASIS study.

Methods

220 patients (146 ocriplasmin, 74 sham) subjects with VMA were enrolled in this masked post hoc analysis phase IIIb, randomised, sham-controlled double-masked multicentre clinical trial. A masked post hoc analysis of OCT images was performed at the Doheny Image Reading Center from subjects enrolled in the OASIS trial. The status of the EZ band was assessed in three different macular regions: the central subfield (CS) (≤1 mm diameter), the parafoveal area (PAA) (>1 to ≤3 mm) and the perifoveal area (PEA) (>3 to ≤6 mm). The EZ band was rated as normal/intact, full thickness macular hole (FTMH), abnormal but continuous, discontinuous/disrupted or absent at visits from baseline (pretreatment) to week 1 (day 7), month 1 (day 28), month 3, month 6, month 12 and the final follow-up at month 24. EZ band status was compared in both study and control eyes.

Results

A total of 208 patients (138 ocriplasmin, 70 sham) were included in this analysis. At baseline, FTMH was present in 48.6%, 8.0%, 0% and 52.8%, 2.9%, 0% in the CS, PAA and PEA of the ocriplasmin and sham groups, respectively. The EZ was graded to be abnormal but continuous, discontinuous/disrupted or absent at Baseline in 21.0%, 4.3%, 2.8% in the CS, PAA and PEA, respectively, of the ocriplasmin group; and 12.9%, 10.0%, 4.3% in the CS, PAA and PEA of the sham group. For the ocriplasmin group in the PAA, this frequency increased to 6.6% at week 1, was 9.8% at month 1, but improved to 3.8% at month 3, and remained stable to 1.6% at month 24. These differences, however, were not statistically significant.

Conclusions

Ocriplasmin treatment for symptomatic VMA was associated with EZ abnormalities in a small percentage of patients that was best assessed in regions (PEA) relatively unaffected by the VM interface disease at baseline. The EZ abnormalities were apparent by week 1, persisted at month 1, and appeared to resolve in the majority of cases by month 3.

Trial registration number

NCT01429441.

SUBMITTER: Velaga SB

PROVIDER: S-EPMC8217951 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSD-OCT is becoming commonplace in everyday practice. Vitreomacular adhesions (VMAs) are being more routinely diagnosed. Predictive studies to the natural course of VMA are thus clinically significant. Spectral domain-optical coherence tomography (SD-OCT) was presently utilized to analyze the incidence of floaters, the complete vitreomacular separation or VMA, the VMA complication, the vitreomacular angle (VMAng), and the complication mechanism.MethodsMonthly SD-OCT was performed on patients with/without symptomatic floaters. OCT allowed VMA and vitreomacular separation to be compared. The incidence was assessed applying one-tailed Fisher's exact tests. The VMAngs between the inner retina and posterior hyaloid were measured, and the complication mechanism was studied using OCT image. For macular hole (MH), pre- and/or post-operative best corrected visual acuities (BCVAs; LogMAR), refractions and photoreceptor conditions were also evaluated.ResultsTotally, 124 eyes were included; there were 116 eyes with VMA and 8 eyes with vitreomacular separation. Considering the percentages over 124 eyes, floaters were present in 14.5% of enrolled eyes (=18/124), consisting of 12.9% of eyes with VMA (16/124) and 1.6% of eyes with vitreomacular separation (2/124). Moreover, there were twelve eyes (9.7%) with VMA-associated vision-threatening complications, including MH (n = 8; 6.5%), retinal detachment (RD; n = 2; 1.6%), vitreomacular traction (VMT; n = 1; 0.8%) and macular pucker (MP; n = 1; 0.8%). Eyes with initial VMA had a significantly greater possibility of complications than eyes with initial vitreomacular separation (p = 0.03). Among these eyes with MH (n = 8), the pre-operative BCVA (LogMAR) was 1.1 ± 0.5, which was insignificantly (p = 0.35) improved to 0.8 ± 0.7 post-operatively. The VMAng of VMA eyes with MHs was 24.2 ± 24.9° (n = 8). The critical VMAng was 13.3°.ConclusionsA minority of eyes with VMA or vitreomacular separation had floaters. Moreover, the use of SD-OCT could identify vision-threatening sequelae, namely MH, RD, MP and VMT, and this was significantly more frequent in eyes with VMA than in eyes with complete vitreomacular separation. Therefore, SD-OCT might be a useful way of identifying either identity, and evaluating VMA-associated complications. Whether VMA eyes with MH (n = 8) that have a VMAng greater than critical VMAng have a greater likelihood of tangential traction and subsequent MH needs further investigation.