Comparison of treatment with the steroid anti-inflammatory loteprednol etabonate and the non-steroidal anti-inflammatory drug (NSAID) bromfenac after cataract surgery.

Comparison of efficacy and safety of postoperative treatment with loteprednol etabonate and bromfenac after phacoemulsification

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN70915202

Enrollment

Registered

2018-05-02

Start date

2013-11-02

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Cataract surgery Eye Diseases

Interventions

All patients used topical ofloxacin 4 times daily for 10 days postoperatively with an addition of the respective topical anti-inflammatory drug. The patients were randomized into 2 groups. Patients in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with age-related cataract undergoing phacoemulsification with posterior chamber intraocular lens (PC IOL) implantation. Patients having uneventful phacoemulsification with PC IOL implantation were enrolled. 2. BCVA between 0.1 and 0.5 3. Cataract nuclear sclerosis in the range between II and III according to LOCS III scale 4. No anti-inflammatory medication for 2 weeks prior to cataract surgery 5. No allergy to loteprednol etabonate (LE) or bromfenac 6. Aged 45-90 years

Exclusion criteria

Exclusion criteria: Patients with ocular infection, glaucoma, uveitis, diabetes, pseudoexfoliation syndrome, prior ocular trauma or intraocular surgery, corneal diseases, ocular tumors, optic nerve atrophy, autoimmune diseases, endocrine, renal, neurological, psychiatric disorders were excluded from the study.

Design outcomes

Primary

Measure	Time frame
Intraocular inflammation assessed by laser flare photometry using Kowa FM -600 (Kowa Co. Ltd). Seven laser flare photometry measurements with values greater than 0 and which backgrounds differed less than 15% were saved. For all patients the highest and the lowest values of flare were excluded, according to the manufacturer’s guidelines. The remaining 5 measurements were averaged. All measurements were taken with undilated pupils. The follow-up examinations were performed on the first day and 1, 4, and 12 weeks postoperatively. Measurements were done at the same time of the day on scheduled visits.	—

Measure

Time frame

Intraocular inflammation assessed by laser flare photometry using Kowa FM -600 (Kowa Co. Ltd). Seven laser flare photometry measurements with values greater than 0 and which backgrounds differed less than 15% were saved. For all patients the highest and the lowest values of flare were excluded, according to the manufacturer’s guidelines. The remaining 5 measurements were averaged. All measurements were taken with undilated pupils. The follow-up examinations were performed on the first day and 1, 4, and 12 weeks postoperatively. Measurements were done at the same time of the day on scheduled visits.

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Secondary

Measure	Time frame
1. Best corrected visual acuity (BCVA) on the Snellen chart 2. Intraocular pressure 3. Anterior and posterior segment evaluation 4. Foveal retina thickness using Optical Coherence Tomography (Topcon 3D OCT-1000 Mark II and Zeiss Stratus OCT Version 4.0.5 (0076) 5. Endothelial cell density measured with Tomey EM-3000 and Topcon SP 2000P Confocal Microscope The follow-up examinations were performed on the first day and 1, 4, and 12 weeks postoperatively. Measurements were done at the same time of the day on scheduled visits.	—

Measure

Time frame

1. Best corrected visual acuity (BCVA) on the Snellen chart 2. Intraocular pressure 3. Anterior and posterior segment evaluation 4. Foveal retina thickness using Optical Coherence Tomography (Topcon 3D OCT-1000 Mark II and Zeiss Stratus OCT Version 4.0.5 (0076) 5. Endothelial cell density measured with Tomey EM-3000 and Topcon SP 2000P Confocal Microscope The follow-up examinations were performed on the first day and 1, 4, and 12 weeks postoperatively. Measurements were done at the same time of the day on scheduled visits.

—

Countries

Poland

Contacts

Public ContactMagdalena Kucharczyk-Pospiech

kucharczykma@gmail.com+48 602 459 228

Outcome results

None listed

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