Condition category
Eye Diseases
Date applied
26/03/2018
Date assigned
02/05/2018
Last edited
17/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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.

Trial website

Contact information

Type

Public

Primary contact

Dr Magdalena Kucharczyk-Pospiech

ORCID ID

Contact details

ul. Zagloby 14/17
Lodz
92-430
Poland
+48 602 459 228
kucharczykma@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

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

Acronym

Study hypothesis

We hypothesise that there will be no difference in postoperative treatment with loteprednol etabonate and bromfenac after phacoemulsification

Ethics approval

Ethics Committee of Medical University of Lodz, 18/09/2012, RNN/164/12/KE.

Study design

Prospective case series

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

05/05/2012

Overall trial end date

30/11/2014

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

58

Participant 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.

Recruitment start date

02/11/2013

Recruitment end date

30/10/2014

Locations

Countries of recruitment

Poland

Trial participating centre

Department of Ophthalmology, Norbert Barlicki Memorial Teaching Hospital No. 1, Medical University of Lodz, Poland Head: Wojciech Omulecki MD, PhD
92-430
Poland

Trial participating centre

Department of Ophthalmology and Visual Rehabilitation, Central Veterans Hospital, Medical University of Lodz, Poland Head: Piotr Jurowski MD, PhD
90-549
Poland

Sponsor information

Organisation

Department of Ophthalmology, Norbert Barlicki Memorial Teaching Hospital No. 1, Medical University of Lodz

Sponsor details

ul. Kopcinskiego 22
Lodz
92-430
Poland

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Medical University of Lodz

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results were submitted for publication by April 2018.

PLD sharing statement
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.

Intention to publish date

31/07/2018

Participant level data

Not expected to be available

Basic results (scientific)

In both groups the statistically significant improvement in BCVA was observed on the 1st day after the surgery (p=0.0001) and between the 1st and the 90th day (p=0.002).
There was no significant difference between groups in BCVA (p=0.049 at 12 weeks).
The laser flare photometry values increased significantly in both groups on the first postoperative day compared with preoperative baseline values (P<0.05). The LFP values were decreasing in both groups from the 1st till 90th day after cataract surgery. There were no statistical significant differences in LFP between preoperative and 90th day after phacoemulsification in both groups (p>0.05) and between the two groups at all time points (p>0.05) (Figure 1).
The central macular thickness was not significantly different after 3 months of treatment in both groups (p=0.594). In one eye of Group I (2.9%) and in one eye of Group II (4.2 %) the pseudophakic cystoid macular edema (PCME) occurred, which totally resolved after 3 months. No long-term vision impairment was observed in these patients. There were no statistical significant differences in central macular thickness between the two groups at all time points (p>0.05) (Figure 2).
The intraocular pressure (IOP) was not significantly different at any time of follow-up in both groups (p>0.05). Preoperatively mean IOP in bromfenac group was 14.6 mmHg and in LE group it was 14.8 mmHg. After 1 month of treatment IOP was 13.6 in Group I and 15.0 in Group II. None of the patients in our study developed a clinically significant IOP elevation.
Mean corneal endothelial cell density decreased from 2487.4 cell/mm2 ± 267.4 preoperatively to 2334.5 cell/mm2 ± 366.678 after 3 months in Group I (9.4%) and from 2293.9 cell/mm2 ± 287.9 to 2233.4 cell/mm2 ± 436.7 in Group II (9.7%). After 3 months of the follow-up there was no statistically significant difference in average corneal endothelium cell density loss between the groups (p>005).

Publication list

Publication citations

Additional files

Editorial Notes