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

Spaeth 1966.

Methods Study design: Randomized, double‐masked, placebo‐controlled 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: USA.
Dates: 1963‐64.
Number randomized: 85: 39 to estrogen, 46 to placebo.
Age: Mean age: estrogen 16.2 years (range 2 to 62 years), placebo 18.9 years (range 0.5 to 65 years).
Sex: 80% of estrogen group, 85% of placebo group were male.
Race: 72% of estrogen group, 70% of placebo group were black; remaining participants were white.
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. More than 24 hours since trauma

  3. History of ocular disease

  4. Failure to co‐operate
Interventions Treatment: Conjugated estrogen, 5 mg intramuscularly for children < 5 years; 10 mg intramuscularly for children 5 years or older but < 10 years; and 20 mg intravenously for children 10 years or older and adults, for 5 days.
Control: Placebo, for 5 days.
Treatment for both groups included:

  1. complete bed rest;

  2. head of bed elevated;

  3. patches on both eyes;

  4. no ophthalmic drops; and

  5. sedation and analgesics as needed.
Outcomes Primary outcome: Risk of secondary hemorrhage, assessed daily by "complete ocular examination" for 5 days. Documentation and definition not reported.
Secondary outcomes:

  1. Time to secondary hemorrhage

  2. VA measured at day 5 (discharge)

  3. Risk of complications and adverse events
Notes Placebo and conjugated estrogen supplied by Ayerst Laboratories.
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) Low risk Allocation was concealed from investigators by use of coded bottles.
Blinding (performance bias and detection bias) 
 Participants Low risk Authors used coded bottles to mask participants. "Neither the person administering nor the patient receiving the medications knew whether estrogen or placebo was being given."
Blinding (performance bias and detection bias) 
 Personnel and outcome assessors Low risk Authors used coded bottles to mask healthcare providers and outcomes assessors. "Neither the person administering nor the patient receiving the medications knew whether estrogen or placebo was being given."
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.