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Table 4 Clinical endpoints reported for ischemic central retinal vein occlusion population in the included studies

From: Systematic literature review of treatments for management of complications of ischemic central retinal vein occlusion

Study (country)

Complication secondary to iCRVO

Study characteristics

BCVA (SD) converted to LogMAR units (Treatment vs. comparator)

CRT (SD) in μm and/or NV (treatment vs. comparator)

Post-treatment complications (treatment vs. comparator)

Quality of evidence (GRADE)*

ANTI-VEGF TREATMENTS

 

Korobelnik et al. 2014 [17] (multinational)

ME

▪ T: Intravitreal aflibercept injection

▪ Mean change in BCVA at: a

▪ Mean reduction in CRT: a

▪ During the 13-month study, NV development: 43 % vs. 43 %

NA

o 13 months: +17.4 (16.1) vs. −8.0 (15.8)

o 494.6 (318.4) vs. 294.3 (258.6)

BCVA could not be converted to LogMAR units as the baseline BCVA was not available

▪ C: Sham injection

Brown et al. 2013 [19] (multinational)

ME

▪ T: Intravitreal aflibercept injection

▪ Proportion of eyes gaining ≥ 15 letters at:

Not given by ischemic status

▪ Not given by ischemic status

NA

o 6 months: 51.4 % vs. 4.3 %

o 13 months: 48.6 % vs. 30.4 %

▪ C: Sham injection

Boyer et al. 2012 [18] (multinational)

ME

▪ T: Intravitreal VEGF Trap-Eye (aflibercept)

▪ Mean change in BCVA at: a

▪ Mean reduction in CRT from baseline to: b

▪ Not given by ischemic status

NA

o 6 months: +17.8 vs. −2.3

BCVA could not be converted to LogMAR units as the baseline was BCVA was not available

o 6 months: 473.0 vs.309.4

▪ C: Sham injection

▪ Proportion of eyes gaining ≥ 15 letters at:

o 6 months: 51.4 % vs. 4.3 %

Wittstrom et al. 2012 [16] (Sweden)

NVG

▪ T: Single intravitreal injection of bevacizumab combined with PRP

▪ Mean baseline BCVA:

▪ Median iris NV grade (range):

NA

low

o 1.8 (0.61) vs. 2.0 (0.43)

o At baseline: 2 (0–4) vs. 1 (0–4)

▪ Mean BCVA at:

o 1 week: 1.8 (0.59) vs. 2.2 (0.45) [p = 0.079]

o 1 week: 0 (0–1) vs. 0 (0–3)

o 2 months: 0 (0–1) vs. 0 (0–2)

o 2 months: 1.8 (0.65) vs. 2.3 (0.46) [p = 0.136]

o 6 months: 0 (0–0) vs.0 (0–1) [for T: p = 0.001, for C: p = 0.005]

▪ C: PRP

o 6 months: 1.7 (0.71) vs. 2.3 (0.55) [p = 0.114]

▪ Median angle NV grade (range):

o At baseline: 1.5 (0–4) vs. 1 (0–4)

o At 1 week: 1 (0–3) vs. 0 (0–3)

o At 2 months: 0 (0–3) vs. 0 (0–3)

o At 6 months: 0 (0–3) vs.0 (0–3) [for T: p = 0.001, for C: p = 0.014]

Campochiaro et al. 2008 [27] (USA)

ME

▪ T: Ranibizumab 0.3 mg (3-monthly injections)

▪ Mean baseline BCVA:

▪ Mean baseline CRT:

NA

moderate

o 0.78 (1.04–0.07) vs. 0.64 (0.96–0.34)

o 346 (88) vs. 297 (126)

▪ Mean BCVA at:

▪ Mean CRT at:

o 3 months: 0.44 vs. 0.56

o 3 months: 25 vs. 35 (eliminating 93 % vs. 89 % of the edema, respectively)

▪ C: Ranibizumab 0.5 mg (3 monthly injections)

STEROID TREATMENTS

 

Asano et al. 2007 [20] (Japan)

Ischemic CME or ME

▪ T: Sub-tenon triamcinolone injection

▪ Mean baseline BCVA:

▪ Mean baseline CRT:

NA

low

o 2 weeks before injection: 0.501 (0.229) vs. 0.510 (0.141)

▪ C: No sub-tenon triamcinolone injection

▪ Mean BCVA at:

o At 2 weeks before injection: 439 (148) vs. 436 (133)

o 1 month: 0.463 (0.359) vs. 0.510 (0.169)

▪ Mean CRT at:

o 2 months: 0.488 (0.262) vs. 0.501 (0.330)

o 1 month: 315 (142) vs. 443 (150)

o 3 months: 0.499 (0.296) vs. 0.501 (0.212)

o 4 months: 0.510 (0.203) vs. 0.511 (0.289)

o 2 months: 442 (143) vs. 467 (152)

o 3 months: 457 (123) vs. 466 (139)

o 4 months: 449 (150) vs. 459 (128)

Ramezani et al. 2006 [21] (Iran)

NV preventive effect

▪ T: Intravitreal triamcinolone

▪ Mean change in BCVA from baseline to:

▪ Mean change in CRT from baseline to:

Not given by ischemic status

very low

o 1 month: −0.40 (0.17) vs. −0.00 (0.12)

o 2 months: −273 (108) vs. −115 (71)

▪ C: Sham subconjunctival injection

Jonas et al. 2005 [26] (Germany)

CME

▪ T: Triamcinolone acetonide intravitreal injection (about 20 mg)

▪ Mean baseline BCVA of ischemic patients in treatment arm:

NA

NA

NA

o 1.79 (0.51)

▪ Mean change in BCVA of ischemic patients in treatment arm:

▪ C: No treatment (results were not given by ischemic status)

o From baseline to best post-operative VA: 1.57 (0.64) [p = 0.10]

PROCEDURAL TREATMENTS

 

Tabatabaii et al. 2008 [23] (Iran)

ME, none of the eyes had NV

▪ T: Pars plana vitrectomy with RON

▪ Mean BCVA:

NA

Post-operation

NA

▪ Iris NV, VH, and increased intraocular pressure in the early post-operative period: 11 %

o Post-operation at 3.6 months vs. pre-operation: 1.32 (0.4–1.9) vs. 1.75 (1.5–1.9) [p < 0.01]

▪ C: Pre-operation

▪ Complicated by retinal detachment requiring pars plana vitrectomy and silicone injection: 5.5 %

▪ Development of NV and VH that needed reoperation: 11 %

Parodi et al. 2007 [22] (Italy and USA)

Anterior-segment NV

▪ T: Conventional PRP (performed promptly when two clock hours of iris NV, any angle NV, or both were identified)

▪ Mean baseline BCVA:

▪ Iris NV (clock hours):

▪ At follow-up, rate of NVG development: 5 % in T and C1 groups, and 11 % in C2 [p = 0.713]

 high

o 1.18 (0.16) vs. 1.19 (0.18) vs. 1.18 (0.15)

o At baseline:3.26 (1.96) [T] vs. 2.95(1.90)[C1] vs. 3.50 (1.97) [C2]

▪ Mean BCVA at:

o 12 months: 1.23 (0.15) [T] vs. 1.20 (0.18) [C1] vs. 1.15 (0.16) [C2] [p = 0.28]

o 1 month: 1.05 (1.12) vs. 3.15 (2.08) vs. 0.27 (0.46)

▪ C1: Selective PRP (performed only in selected cases showing progression of iris NV, angle NV, or both during weekly follow-up)

o 6 months: 0.47 (1.07) vs. 3.05 (2.21) vs. 1.77 (1.11)

o 12 months: 0.52 (2.29) vs. 2.55 (3.05) vs. 2.27 (2.37)

▪ C2: Photodynamic therapy with verteporfin (directed at the iris NV and angle NV)

▪ Angle NV (clock hours):

o At baseline:1.94 (1.12) [T] vs. 1.85 (1.34) [C1] vs. 2.38 (1.88) [C2]

o 1 month: 0.68 (0.88) vs. 2.15 (1.81) vs. 0.00 (0.00)

o 6 months: 0.52 (1.64) vs. 2.15 (1.89) vs. 0.83 (1.24)

o 12 months: 0.57 (2.52) vs. 1.50 (2.64) vs. 1.27 (2.49)

Feltgen et al. 2007 [24] (Germany)

Not mentioned

▪ T: Retinal endovascular lysis

▪ Mean pre-operative BCVA immediately before surgery:

NA

▪ Rate of post-operative complication development:

NA

▪ C: Pre-operation

o +1.2 (SEM +1.6/ minus +1.745) (range, +2.6 to +0.70) (N.B: +2.6 = light perception)

o NV: 46 %

o Retinal detachment: 23 %

▪ Mean post-operative BCVA at:

o Cataract: 31 %

▪ Rate of intra-operative complications:

o 6 weeks: +1.31 (SEM plus +1.62/ minus +1.80) (range, +2.6 to +0.4)

o Serious retinal detachment: 8 %

o 3 months: +1.37 (SEM plus +1.72/ minus +1.85) (range, +2.6 to +0.52)

o VH: 31 %

▪ To treat these complications, 13 eyes required 22 additional procedures

o 6 months: +1.46 (SEM plus +1.66/ minus +1.89) (range, +2.9 to +0.4) (N.B: +2.9 = Blindness)

o 12 months: +1.40 (SEM plus 1.58/ minus +1.80) (range, +2.9 to +0.4)

[None of these differences were significant]

Mirshahi et al. 2005 [25] (Iran)

Prevention of NV

▪ T: Surgical induction of chorioretinal venous anastomosis

▪ Mean BCVA at time period from the onset of occlusion to the time of referral:

NA

▪ Three (30 %) of 10 patients in the treatment arm needed further operations for:

NA

o 2.5 vs. 1.5 [p < 0.001]

▪ C: No surgery

▪ Change in BCVA after the occurrence of occlusion:

o Cataract: 33.3 %

o Vitreous cavity hemorrhage: 33.3 %

o 8 months: gained 0.94 vs. lost 0.57 [p < 0.001]

o Retinal detachment: 33.3 %

o NV: 0 %

▪ In the control group, 7 (39 %) of 18 patients developed NV:

o NVG: 57 %

o Disc NV: 29 %

o Iris NV: 14 %

MISCELLANEOUS TREATMENTS

 

Hayreh et al. 2011 [28] (USA)

Not mentioned

▪ T: Aspirin

▪ Baseline BCVA (n = 38 vs. 45 eyes) (p = 0.905)

NA

NA

NA

▪ C: No aspirin or anticoagulant

o Better than 0.5: 0 (0 %) vs. 0 (0 %)

o 0.5–0.7: 1 (3 %) vs. 0 (0 %)

o 1.0–1.3: 7 (18 %) vs. 11 (24 %)

o CF or worse: 30 (79 %) vs. 34 (76 %)

▪ Improved BCVA −0.5 or worse at:

o 3 months (n = 26 vs. 32): 2 (8 %) vs. 4 (12 %)

o 6 months (n = 22 vs. 29): 3 (14 %) vs. 5 (17 %)

o 9 months (n = 18 vs. 32): 3 (17 %) vs. 5 (16 %)

o 15 months (n = 16 vs. 21): 5 (31 %) vs. 5 (24 %)

o 2–5 years (n = 9 vs. 17): 2 (22 %) vs. 4 (24 %)

▪ Worsened BCVA −0.5 or worse at:

o 3 months (n = 26 vs. 32): 5 (19 %) vs. 4 (12 %)

o 6 months (n = 22 vs. 29):4 (18 %) vs. 6 (21 %)

o 9 months (n = 18 vs. 32): 2 (11 %) vs. 8 (25 %)

o 15 months (n = 16 vs. 21): 4 (25 %) vs. 5 (24 %)

o 2–5 years (n = 9 vs. 17): 3 (33 %) vs. 5 (29 %)

  1. BCVA best corrected visual acuity, C comparator, CME cystoid macular edema, CRT central retinal thickness, iCRVO ischemic central retinal vein occlusion, LogMAR logarithm of the minimum angle of resolution, ME macular edema, NA not available/not applicable, NV neovascularization, NVG neovascular glaucoma, PRP panretinal photocoagulation, RON radial optic neurotomy, SD standard deviation, SEM standard error mean, T treatment, VEGF vascular endothelial growth factor
  2. aBaseline data were not reported for ischemic patients separately
  3. bQuality of evidence were assessed using GRADEpro version 3.6. In order to provide overall consistency in grading methods across studies of primary interest, only prospective, randomized, controlled / uncontrolled clinical trial studies were assessed [45]