Skip to main content
. 2019 Jan 14;2019(1):CD005431. doi: 10.1002/14651858.CD005431.pub4

Vangsted 1983.

Methods Study design: Randomized clinical trial.
Exclusions after randomization: None.
Losses to follow‐up: None.
Intention‐to‐treat: All participants were analyzed in the group to which they had been randomly assigned.
Sample size calculations: Not reported.
Participants Country: Sweden.
Dates: November 1978 to May 1981.
Number randomized: 112: 59 to tranexamic acid, 53 to bed rest.
Age: Mean age: tranexamic acid group 23.5 years (range 9 to 60 years), bed rest group 23.5 years (range 9 to 67 years).
Sex: Ratio of male:female 4:1.
Race: Not reported.
Sickle cell disease: Not reported.
Participants appeared to be balanced with respect to baseline characteristics.
Inclusion criteria: Traumatic hyphema.
Exclusion criteria:

  1. Penetrating ocular injury

  2. Microscopic hyphema

  3. More than 24 hours since trauma

  4. Younger than 8 years of age

  5. History of renal disease with creatine > 115 μmol/L

  6. Serious blood dyscrasia or earlier thrombotic disease

  7. Pregnancy
Interventions Treatment: Oral tranexamic acid 25 mg/kg 3 times/day, for 7 days.
Control: Complete bed rest for 6 days.
Treatment for both groups included:

  1. patch on affected eye;

  2. 1% atropine once/day;

  3. dexamethasone 3 times/day;

  4. no aspirin; and

  5. oral acetazolamide if IOP > 25 mmHg.
Outcomes Primary outcome: Risk of secondary hemorrhage, assessed daily by slit‐lamp exam at days 2 and 7. Documentation and definition not reported.
Secondary outcomes:

  1. Time to resolution of primary hemorrhage

  2. VA measured at days 2 and 7

  3. IOP measured using applanation tonometry at days 2 and 7

  4. Length of hospitalization

  5. Risk of complications and adverse events
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomized, but method of allocation not reported.
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not reported.
Blinding (performance bias and detection bias) 
 Participants High risk Participants were not masked to treatment assignment (bed rest vs tranexamic acid).
Blinding (performance bias and detection bias) 
 Personnel and outcome assessors High risk Healthcare providers and outcome assessors were not masked to treatment assignment (bed rest vs tranexamic acid).
Incomplete outcome data (attrition bias) 
 Primary outcome Low risk There were no exclusions and no loss to follow‐up. All participants were analyzed in the group to which they had been randomly assigned.
Incomplete outcome data (attrition bias) 
 Secondary outcomes Low risk There were no exclusions and no loss to follow‐up. All participants were analyzed in the group to which they had been randomly assigned.
Selective reporting (reporting bias) Low risk Reported results for primary and secondary outcomes
Other bias Low risk No other sources of potential bias were identified.