Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery

NCT01542190 | Completed Phase 4

• 1 other identifier: 0018014600011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery. Patients scheduled to undergo phacoemulsification will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group) for three days preoperatively and four weeks postoperatively. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema.

Conditions

Cystoid Macular Edema Following Cataract Surgery, Bilateral

Keywords

cataract surgery; cystoid macular edema; angiography

Outcome Measures

Primary Outcomes (1)

• cystoid macular edema

  Angiography (Miyake's criteria)

  1 month

Secondary Outcomes (1)

• Best corrected visual acuity

  1 month

Study Arms (2)

ketorolac tromethamine

ACTIVE COMPARATOR

Drug: Ketorolac Tromethamine

Dextrano 70 / Hypromellose

PLACEBO COMPARATOR

Drug: Ketorolac Tromethamine

Interventions

Ketorolac Tromethamine DRUG

ketorolac tromethamine 0.4%

Also known as: Acular LS (Allergan), Lacribell (Latinofarma)

Dextrano 70 / Hypromellose; ketorolac tromethamine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with nuclear cataract, density 1 and 2 classified by LOCS II, scheduled to undergo phacoemulsification cataract surgery.

You may not qualify if:

• Patients with:
• Diabetes,
• Hypertension,
• uveitis,
• macular disease,
• congenital ocular abnormalities,
• cataract density 0 and 3 by LOCS II,
• pseudoexfoliation syndrome.
• Patients under treatment with nonsteroidal antinflammatory drugs or topical eye drops were excluded.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (2)

Unicamp

Campinas, São Paulo, 13083970, Brazil

Location

Unicamp

Campinas, São Paulo, Brazil

Location

Related Publications (8)

• Miyake K, Masuda K, Shirato S, Oshika T, Eguchi K, Hoshi H, Majima Y, Kimura W, Hayashi F. Comparison of diclofenac and fluorometholone in preventing cystoid macular edema after small incision cataract surgery: a multicentered prospective trial. Jpn J Ophthalmol. 2000 Jan-Feb;44(1):58-67. doi: 10.1016/s0021-5155(99)00176-8.

  PMID: 10698027 BACKGROUND

• Miyake K, Ibaraki N. Prostaglandins and cystoid macular edema. Surv Ophthalmol. 2002 Aug;47 Suppl 1:S203-18. doi: 10.1016/s0039-6257(02)00294-1.

  PMID: 12204717 BACKGROUND

• Kim A, Stark WJ. Are topical NSAIDs needed for routine cataract surgery? Am J Ophthalmol. 2008 Oct;146(4):483-5. doi: 10.1016/j.ajo.2008.07.027. No abstract available.

  PMID: 18804560 BACKGROUND

• Gass JD, Norton EW. Cystoid macular edema and papilledema following cataract extraction. A fluorescein fundoscopic and angiographic study. Arch Ophthalmol. 1966 Nov;76(5):646-61. doi: 10.1001/archopht.1966.03850010648005. No abstract available.

  PMID: 5955948 BACKGROUND

• Miyake K. Prevention of cystoid macular edema after lens extraction by topical indomethacin (I). A preliminary report. Albrecht Von Graefes Arch Klin Exp Ophthalmol. 1977 Aug 8;203(2):81-8. doi: 10.1007/BF00413399.

  PMID: 303062 BACKGROUND

• Miyake K, Ota I, Miyake G, Numaga J. Nepafenac 0.1% versus fluorometholone 0.1% for preventing cystoid macular edema after cataract surgery. J Cataract Refract Surg. 2011 Sep;37(9):1581-8. doi: 10.1016/j.jcrs.2011.03.052.

  PMID: 21855758 BACKGROUND

• Rossetti L, Chaudhuri J, Dickersin K. Medical prophylaxis and treatment of cystoid macular edema after cataract surgery. The results of a meta-analysis. Ophthalmology. 1998 Mar;105(3):397-405. doi: 10.1016/S0161-6420(98)93018-4.

  PMID: 9499767 BACKGROUND

• Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.

  PMID: 18599019 BACKGROUND

Related Links

• Estate University of Campinas

MeSH Terms

Conditions

Macular Edema

Interventions

Ketorolac Tromethamine; Ketorolac

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rodrigo PC Lira

  University of Campinas, Brazil

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: March 2, 2012
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: August 1, 2013
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

BR (2)