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. 2019 Jan 14;2019(1):CD005431. doi: 10.1002/14651858.CD005431.pub4

Rahmani 1999.

Methods Study design: Randomized, placebo‐controlled clinical trial.
Exclusions after randomization: 6: 2 participants in the tranexamic acid group, 3 in the prednisone group, and 1 in the placebo group left the hospital before the end of the study and were excluded.
Losses to follow‐up: None.
Intention‐to‐treat: The excluded participants were not included in the analyses, and the intention‐to‐treat principle was not followed in the analyses.
Sample size calculations: Not reported.
Participants Country: Iran.
Dates: January 1991 to May 1992.
Number randomized: 244: 82 to tranexamic acid, 81 to prednisone, 81 to placebo.
Age: Median age: tranexamic acid 11 years (range 1 to 65 years); prednisone 11.5 years (range 1 to 50 years); placebo 12 years (range 1 to 58 years).
Sex: 63 participants (79%) in tranexamic acid group, 58 participants (73%) in prednisone group, and 66 participants (82%) in placebo group were male.
Race: 100% white.
Sickle cell disease: Not reported, but all‐white study population.
Participants appeared to be balanced with respect to baseline characteristics.
Inclusion criteria: Traumatic hyphema.
Exclusion criteria:

  1. Penetrating ocular injury

  2. Total hyphema or unlayered microscopic hyphema

  3. Definite secondary hemorrhage before entry

  4. More than 48 hours since trauma

  5. Requirement for immediate surgical intervention

  6. History of renal insufficiency

  7. Acid peptic disease

  8. Recent ingestion of aspirin or anticoagulant

  9. Use of topical corticosteroids after trauma

  10. Pregnancy
Interventions Treatment 1: Oral tranexamic acid 75 mg/kg per day, divided into 3 doses/day, for 5 days.
Treatment 2: Oral prednisolone 0.75 mg/kg per day, divided into 2 doses/day, for 5 days.
Control: Placebo administered 3 times/day.
Treatment for all groups included:

  1. limited ambulation;

  2. head of bed elevated;

  3. patch and shield on affected eye;

  4. topical cyclopentolate for exam of the retina if necessary;

  5. oral paracetamol for pain;

  6. no aspirin or topical corticosteroids;

  7. topical timolol and oral acetazolamide, if elevated IOP; and

  8. oral promethazine if nausea or vomiting.
Outcomes Primary outcome: Risk of secondary hemorrhage, assessed daily by slit‐lamp exam for 5 days. Defined as definite increase in size of level of blood or appearance of fresh blood over darker clotted blood in the anterior chamber.
Secondary outcomes:

  1. VA, measured at day 5 (discharge)

  2. Risk of complications and adverse events
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization was based on a randomization list.
Allocation concealment (selection bias) Unclear risk Participants were assigned to treatment groups using a randomization list, but it was not clear whether list was revealed before allocation to individuals enrolling participants.
Blinding (performance bias and detection bias) 
 Participants Unclear risk Participants partially masked as authors used a placebo control for the tranexamic acid, but not for prednisone.
Blinding (performance bias and detection bias) 
 Personnel and outcome assessors Low risk Healthcare providers partially masked as authors used a placebo control for the tranexamic acid, but not for prednisone; however, ophthalmologists and outcome assessors were masked.
Incomplete outcome data (attrition bias) 
 Primary outcome Unclear risk 6 participants were excluded from the study: 2 in the tranexamic acid group, 3 in the prednisone group, and 1 in the placebo group left the hospital before the end of the study and were excluded. The excluded participants were not included in the analyses, and the intention‐to‐treat principle was not followed in the analyses.
Incomplete outcome data (attrition bias) 
 Secondary outcomes Unclear risk 6 participants were excluded from the study: 2 in the tranexamic acid group, 3 in the prednisone group, and 1 in the placebo group left the hospital before the end of the study and were excluded. The excluded participants were not included in the analyses, and the intention‐to‐treat principle was not followed in the analyses.
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.