Effect of diclofenac-sodium, unpreserved diclofenac-sodium or ketorolac on the inflammatory response after cataract surgery

Active, not recruiting

• Conditions: intraocular inflammatory reaction after cataract-surgery

• Registration Number: EUCTR2004-005287-24-AT
• Lead Sponsor: niv.-Kl. f.Augenheilkunde und Optometrie Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-24
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Male/Female patients suitable for phacoemulsification cataract surgery
Aged 40-90 years
Able and willing to give Informed Consent

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

A)Pre-operative: History
1.Presence of pre-proliferative and proliferative diabetic retinopathy with or without diabetic maculopathy
2.Patients with severe systemic dysfunction
3.Ocular surgery or laser therapy, especially if recent, in the operative eye
4.Hypersensitivity to: Diclofenac-sodium, Ketorolac-Trometamol , Prednisolon-21-acetate or any ingredient of the concomitant or study medication
5.Recent treatment with ophthalmic local or systemic anti-inflammatory drugs
6. History of intraocular inflammation / uveitis
B)Pre-operative: Examination
1.Ocular malformations like microphthalmia
2.Significant anterior segment ocular disease involving the cornea or uvea
3.Concurrent inflammatory/infective eye disorder e.g. conjunctivitis, episcleritis, blepharitis other than mild seborrhoic blepharitis etc.
4.Severe dry eye syndrome (needing ocular lubricants more than 6 times per day)
5.Cataract secondary to ocular injury/inflammatory eye disease
6.Ocular hypertension or glaucoma under treatment with topical medications other than topical beta-blockers used for at least 28 days prior to study admission
7.Intra-ocular pressure > 26mm Hg with or without treatment
8.Any other disease e.g. pseudo-exfoliation in the operative eye which makes the subject unsuitable for the trial
C)Surgery not performed according to the standard operating procedure
D)Intra-operative complications and medication:
1.significant corneal, iris or vitreal damage
2.excessive cortical remnants
3.significant anterior chamber bleeding
4.intraocular lens not implanted or significant dislocation of the implant
5.any medication other than those listed in the standard operation procedure for cataract surgery
E)Post-operative complications on day 1:
1.wound dehiscence/iris prolapse requiring re-suturing
2.fibrin in the anterior chamber
3.severe intraocular inflammation, infection or bleeding
4.intraocular lens dislocation i.e. optical center of the lens more than 2mm out of the optic axis
5.any other complications e.g. severe conjunctival chemosis on day 1 in the operative eye, considered by the investigator to be adequately significant to interfere with the trial
F)Concomitant medication (added post-operative)
1.Any topical ophthalmic medication in the operative eye other than the study medication, artificial tear substitutes and topical antibiotics.
2.Anti-inflammatory systemic medication; however, the use of OTC anti-inflammatory and analgesic drugs such as acetyl salicylic acid and paracetamol for minor conditions
(e.g. headache) is acceptable if not more than 2000 mgs per week.
G)Others
1.Non compliant patients (e.g. not willing to attend the follow up visits)
2.Pregnant or lactating patients or of childbearing potential.
3.Contact lens wearer during the treatment period
4.Known substance abuse (including alcoholism)
5.Participation in another clinical trial
6.Mentally handicapped patients
7.Judged by the investigator to be unsuitable for the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective of the trial is the reduction of intraocular inflammatory reaction (flare) after catarct surgery by topical use of eye drops with anti-inflammatory effect.;Secondary Objective: Secondary objectives are the inhibition of cystoid macular edema / retinal thickening after catarct surgery by topical use of eye drops with anti-inflammatory effect.;Primary end point(s): Completion of post-surgical topical therapy 4 weeks after cataract-surgery.