Prevention of pseudophakic cystoid macula oedema with pre- and postoperative ketorolac - Prevention of CMO with pre and postop ketorolac

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001843-20-GB

Enrollment

1390

Registered

2008-08-06

Start date

2008-10-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cystoid macula oedema

Interventions

Trade Name: Acular Product Name: ketorolac Pharmaceutical Form: Eye drops* INN or Proposed INN: KETOROLAC TROMETHAMINE CAS Number: 74103074 Concentration unit: % (V/V) percent volume/volume Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing routine cataract surgery (without an additional procedure) at Frimley Park Hospital Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who have previously had a reaction to ketorolac and those on systemic nonsteroidal anti-inflammatories or steroids will be excluded. Patients under 18 years of age.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To document adverse effects of topical ketorolac use. To assess changes in contrast sensitivity with topical ketorolac;Primary end point(s): Change in Central macula thickness ( measured in nm on an optical coherence topography scan - noninvasive) Change in visual acuity assessed on a LogMAR chart (noninvasive);Main Objective: To assess whether the use of topical ketorolac 3 days pre operatively and 3 weeks post cataract surgery reduces the incidence of pseudophakic cystoid macula oedema	—

Measure

Time frame

Secondary Objective: To document adverse effects of topical ketorolac use. To assess changes in contrast sensitivity with topical ketorolac;Primary end point(s): Change in Central macula thickness ( measured in nm on an optical coherence topography scan - noninvasive) Change in visual acuity assessed on a LogMAR chart (noninvasive);Main Objective: To assess whether the use of topical ketorolac 3 days pre operatively and 3 weeks post cataract surgery reduces the incidence of pseudophakic cystoid macula oedema

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026