Comparison of treatment with the steroid anti-inflammatory loteprednol etabonate and the non-steroidal anti-inflammatory drug (NSAID) bromfenac after cataract surgery.
| ISRCTN | ISRCTN70915202 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70915202 |
| Secondary identifying numbers | 1 |
- Submission date
- 26/03/2018
- Registration date
- 02/05/2018
- Last edited
- 07/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
After cataract surgery, patients need to use eye drops to reduce inflammation of the eye. Suitable medicines include non-steroidal anti-inflammatory drugs (NSAIDs) and steroids and they can be applied alone or in combination. However, steroid eye drops can cause an increase in pressure inside the eye.
The aim of this study is to investigate if using the NSAID bromfenac after cataract surgery has reduced side effects compared with the steroid loteprednol etabonate. This is the first study where bromfenac is administered alone after phacoemulsification. In previous studies it was administered in combination with a steroid drug. Bromfenac is an effective anti-inflammatory after cataract surgery and could simplify the number of eye drops patients have to use. This might reduce costs and side effects.
Who can participate?
Patients aged 45-90 years with age-related cataract undergoing phacoemulsification cataract surgery with posterior chamber intraocular lens implantation, in which the lens is removed and replaced with an artificial lens.
What does this study involve?
All participants will use ofloxacin (an antibiotic) as eye drops for 10 days after the operation. Patients in Group I will use bromfenac eye drops 2 times a day for 30 days after the operation. Patients in Group II will use loteprednol etabonate eye drops 4 times daily for 30 days after the operation.
What are possible benefits and risks of participating?
There are no known side-effects of bromfenac administered after phacoemulsification. Both drugs are approved by medicine regulatory bodies. There was no risk of participating in this study.
Where is the study run from?
There are two medical centers taking part in this study. The lead center is Department of Ophthalmology, Norbert Barlicki Memorial Teaching Hospital No. 1, Medical University of Lodz, Poland. Head: Wojciech Omulecki MD, PhD. The second center is Department of Ophthalmology and Visual Rehabilitation, Central Veterans Hospital in Lodz. Medical University of Lodz, Poland Head: Piotr Jurowski MD, PhD
When is study starting and how long is it expected to run for?
The start date was 5/05/2012 and the trial ran until 30/11/2014
Who is funding the study?
The study funder is Department of Ophthalmology, Norbert Barlicki Memorial Teaching Hospital No. 1, Medical University of Lodz, Poland and this department will be paying the costs that trial will incur during its lifecycle.
Who is the main contact?
Magdalena Kucharczyk-Pospiech, kucharczykma@gmail.com.
Contact information
Public
ul. Zagloby 14/17
Lodz
92-430
Poland
| Phone | +48 602 459 228 |
|---|---|
| kucharczykma@gmail.com |
Study information
| Study design | Prospective case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Comparison of efficacy and safety of postoperative treatment with loteprednol etabonate and bromfenac after phacoemulsification |
| Study objectives | We hypothesise that there will be no difference in postoperative treatment with loteprednol etabonate and bromfenac after phacoemulsification |
| Ethics approval(s) | Ethics Committee of Medical University of Lodz, 18/09/2012, RNN/164/12/KE. |
| Health condition(s) or problem(s) studied | Cataract surgery |
| Intervention | 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 Group I used a non-steroidal anti-inflammatory drug (0.09% bromfenac) 2 times daily for 30 days postoperatively. Patients in Group II used a steroidal anti-inflammatory drug (0.5% loteprednol etabonate) 4 times daily for 30 days postoperatively. Consecutive 58 patients (58 eyes) were randomly assigned to the one of the study groups regarding postoperative treatment. The follow-up examinations were performed on the first day and 1, 4, and 12 weeks postoperatively. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | bromfenac, loteprednol etabonate |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 05/05/2012 |
| Completion date | 30/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 58 |
| Total final enrolment | 58 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 02/11/2013 |
| Date of final enrolment | 30/10/2014 |
Locations
Countries of recruitment
- Poland
Study participating centres
Poland
Poland
Sponsor information
University/education
ul. Kopcinskiego 22
Lodz
92-430
Poland
"ROR" |
https://ror.org/02t4ekc95 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results were submitted for publication by April 2018. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available because we did not receive agreement from our patients to share the data with other institutions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2019 | 07/11/2019 | Yes | No |
Editorial Notes
07/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
