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. 2016 Nov 1;2016(11):CD006683. doi: 10.1002/14651858.CD006683.pub3

Tunc 1999.

Methods Study design: Parallel group RCT
Participants Country: Turkey
Setting: Eye hospital
Intervention: NSAIDs plus steroids
  • Number of people (eyes) randomised: 50 (50)

  • Number (%) of people followed up: 50 (100%)

  • Average age in years: 61

  • Age range in years: NR

  • Percentage women: 38%

  • Ethnic group: NR

  • Percentage with diabetes: 0 (excluded)

  • Percentage with uveitis: 0 (excluded)


Comparator: Steroids alone
  • Number of people (eyes) randomised: 25 (25)

  • Number (%) of people followed up: 25 (100%)

  • Average age in years: 65

  • Age range in years: NR

  • Percentage women: 40%

  • Ethnic group: NR

  • Percentage with diabetes: 0 (excluded)

  • Percentage with uveitis: 0 (excluded)


Inclusion criteria: Patients with unilateral cataracts.
Exclusion criteria: Diabetes; rheumatoid disease; immunological disease; uveitis; glaucoma; ARMD; retinitis pigmentosa; retinal detachment; NSAIDs use; corticosteroid use; diuretic use; antihistaminics; previous eye surgery; surgical complications (e.g.. posterior capsular tear, vitreous loss, iatrogenic iridodialysis); combined surgery; postoperative complications (e.g.. iris capture, retinal detachment, choroidal detachment); non‐compliance with medications; use of systemic steroids or NSAIDs during the follow‐up period; definite posterior capsule opacification.
Pretreatment: No differences in age sex, and hypertension.
Eyes: One eye, people with unilateral cataracts recruited.
Interventions Intervention: NSAIDs plus steroids
  • diclofenac sodium 0.1% (brand name not reported)

    • Times per day: 4 times

    • Duration preoperative: days: 1

    • Duration postoperative: days: 56

  • dexamethasone sodium phosphate 1% (brand name not reported)

    • Times per day: 4 times a day for 21 days; 3 times a day from day 22 to 56

    • Duration preoperative: days: 0

    • Duration postoperative: days: 56


Comparator: Steroids alone
  • dexamethasone sodium 1% (brand name not reported)

  • Times per day: 4 times a day for 21 days, 3 times a day from day 22 to 56

  • Duration preoperative: days: 0

  • Duration postoperative: days: 56


At the end of surgery all participants had subconjunctival injection of dexamethasone and gentamicin. All participants used 0.03% tobramycin eye drops postoperatively 4 times a day for 14 days.
Type of surgery: ECCE
Outcomes Follow‐up: 2 months
  • CMO (fluorescein angiography 0 no leakage (CME absent),1 oedema less than perifoveal, 2 mild perifoveal oedema, 3 moderate perifoveal oedema (approx 1 disc diameter), 4 severe perifoveal oedema plus drop of 1 line of Snellen acuity since second postoperative week defined as "clinically significant")

Contact details Authors name: Murat Tunc
Institution: Dokuz Eylul University Medical School
Email: NR
Address: Dokuz Eylul University Cumhuriyet Blv No:144, 35210 Alsancak/İzmir, Turkey
Notes Funding sources: NR
Declaration of interest: NR
Date study conducted: NR
Trial registration number: NR
Contacting study investigators: Trial authors not contacted.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgement comment: Not reported how list was generated. Trial was described as “randomised” but with no further details.
Allocation concealment (selection bias) Unclear risk Judgement comment: Not reported how allocation administered. Trial was described as “randomised” but with no further details.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No information on masking. We assume that in absence of reporting on this participants and personnel were not masked.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "The angiograms were read by the retina unit (Dr Saatchi); the patients' names and treatment protocols were kept hidden.
Judgement quote: No other information on other outcomes.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Judgement Comment: Follow‐up not reported.
Selective reporting (reporting bias) Unclear risk Judgement Comment: No access to protocol or trial registry entry.