Table 4.
Methods | Study type | Prospective non-randomized clinical interventional study |
---|---|---|
Enrollment method | Not stated | |
Inclusion criteria | Not stated | |
Exclusion criteria | Not stated | |
Follow up | 10.1 +/− 8.6 months in intervention group 6.0 +/− 5.2 months in control group |
|
Funding source | “No proprietary interest” | |
Notes | Unclear as to why follow-up rates differed between intervention and control group; decision to offer patients IVTA depended on examining ophthalmologist, time of recruitment, and patient preference | |
Participants | Country | Heidelberg, Germany |
Study period | Not stated | |
No. of eyes | 33 eyes of 32 Patients (13 eyes treatment, 20 eyes control) | |
Baseline characteristics | Equivalent | |
Notes | Exclusion criteria not stated in study; while treatment group had symptoms at least 3 months prior to IVTA, unclear how long symptoms present in observation group; initial VA of observation group higher than initial VA of treatment group (0.64 0.38 logMAR versus 1.20 0.55 logMAR); according to FA, 46% of treatment group had ischemic CRVO versus 20% of observation group | |
Interventions | Treatment | 20 to 25 mg (0.2 ml) of triamcinolone acetonide |
Control | Observation | |
Notes | Routine paracentesis | |
Outcomes | VA compared to baseline | Treatment: VA returned to baseline approximately 5 months s/p IVTA Control: VA did not differ significantly at end of follow up compared to baseline, P = 0.42 |
Complications | Although IOP rise was significantly higher in treatment group versus observation group (P = 0.007) during study, neither group varied significantly at end of follow up (P = 0.65) | |
Subgroup analysis: ischemic treatment versus non-ischemic treatment | Ischemic (n = 4): VA did not vary significantly (P = 0.10) from baseline to best postoperative VA (1.57 0.64 logMAR) Non-ischemic (n = 9): VA increased significantly (P = 0.04) from baseline to best postoperative VA (0.69 0.25 logMAR) |
|
Notes | Throughout study, VA results are not compared between treatment and observation groups; rather, P values represent VA changes compared to baseline within a group; FA not performed regularly for all patients in study; for subgroup analysis, pre-operative VA was significantly higher (P = 0.003) in non-ischemic CRVO (0.93 0.32 logMAR versus 1.79 0.51 logMAR) |
CRVO: central retinal vein occlusion
FA: fluorescein angiography
IOP: intraocular pressure
IVTA: intravitreal triamcinolone
s/p: status post
VA: visual acuity