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

Spoor 1980.

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: September 1975 to December 1977.
Number randomized: 43: 23 to prednisone, 20 to placebo.
Age: Mean age: prednisone group 20.1 years (range 5 to 61 years), placebo group 21.2 years (range 9 to 51 years).
Sex: 16 (70%) of prednisone group, 16 (80%) of placebo group were male.
Race: 14 (61%) white participants, 6 (26%) Hispanic participants, and 3 (13%) black participants in prednisone group; 11 (55%) white participants, 7 (35%) Hispanic participants, and 2 (10%) black participants in placebo group.
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. Treated before entry

  4. Not available for 6 months follow‐up
Interventions Treatment: Oral prednisone 40 mg/day for adults and children > 10 years; 15 mg/day for children ages 4 to 10 years; and 10 mg/day for children ages 18 months to 4 years, for 7 days.
Control: Lactose placebo capsules administered daily for 7 days.
Treatment for both groups included:

  1. bed rest;

  2. head of bed elevated 30° to 45°;

  3. patch on affected eye;

  4. no topical medications;

  5. sedation as needed;

  6. no aspirin; and

  7. oral acetazolamide if IOP > 24 mmHg.
Outcomes Primary outcome: Risk of secondary hemorrhage, assessed daily for 7 days, using slit‐lamp exam, documented by drawings or photography.
Secondary outcomes:

  1. Time to resolution of primary hemorrhage

  2. Time to secondary hemorrhage

  3. VA (followed up to 6 months)

  4. IOP assessed daily for 7 days using applanation tonometry

  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) Low risk Allocation was concealed from investigators by use of encoded capsules prepared by pharmacy.
Blinding (performance bias and detection bias) 
 Participants Low risk Participants masked to treatment assignment by use of encoded capsules prepared by pharmacy. "Neither the doctor nor the patient knew which capsule the patient was receiving until the conclusion of the course of treatment and follow‐up."
Blinding (performance bias and detection bias) 
 Personnel and outcome assessors Low risk Healthcare providers and outcomes assessors masked to treatment assignment by use of encoded capsules prepared by pharmacy. "Neither the doctor nor the patient knew which capsule the patient was receiving until the conclusion of the course of treatment and follow‐up."
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.