Condition category
Eye Diseases
Date applied
14/12/2010
Date assigned
22/12/2010
Last edited
22/12/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Supawat Trepatchayakorn

ORCID ID

Contact details

Department of Ophthalmology
Faculty of Medicine
Chulalongkorn University
1873 Rama 4 Road
Pathumwan
Bangkok
10330
Thailand

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Nepafenac and prevention of cystoid macular edema (CME) after cataract surgery in patients receiving latanoprost: a randomised controlled trial

Acronym

Study hypothesis

To evaluate whether there is a potential benefit, in term of cystoid macular edema (CME) prevention, in the administration of nepafenac and/or discontinuation of latanoprost in patients receiving latanoprost undergoing uneventful cataract surgery by phacoemulsification and intraocular lens (IOL) implantation.

Ethics approval

Institutional Review Board, Faculty of Medicine, Chulalongkorn University, approved on the 14th October 2010 (ref: COA no.514/2010 IRB no.241/53)

Study design

Randomised double-masked controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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

Cystoid macular edema (CME)

Intervention

Only eyes received 0.005% Latanoprost at least 1-month prior to a planned phacoemulsification with PC-IOL implantation, would be included, as indicated in the inclusion criteria. Subjects that were met with inclusion and exclusion criteria will be randomly assigned using block-of-six to one of the following three groups:
Group 1: 0.005% Latanoprost ed
Group 2: 0.005% Latanoprost ed and 0.1% Nepafenac ed
Group 3: artificial tears as Latanoprost placebo

0.005% Latanoprost and Latanoprost placebo are masked and given once daily before bedtime, starting from the first day after cataract surgery until the study endpoint at the 10th post-operative week. 0.1% Nepafenac (Nevanac; Alcon Inc., Fort Worth, Tx, USA) is given 3 times daily 3 days before surgery until the 3rd post-operative week.

All subjects undergo a clear corneal incision, phacoemulsification, and intraocular lens implantation using an acrylic foldable IOL (AcrysofIQ; Alcon Inc., Fort Worth, Tx, USA). Post-operative regimen includes 0.5% Moxifloxacin (Vigamox; Alcon Inc., Fort Worth, Tx, USA) given qid for 1 month, and 1% Prednisolone acetate (Pred-Forte; Allergan Inc., Westport, Ireland) given q2h x1d, qid x4wk then tid x4wk.

Intervention type

Drug

Phase

Phase III

Drug names

Nepafenac, latanoprost

Primary outcome measures

Difference in incidence of post-operative CME - detected with OCT and measured up to 10 weeks accumulatively - between either approaches: discontinuation of Latanoprost or continuing Latanoprost but with the administration of Nepafenac, compared with a group of patients who continue to use Latanoprost as previously used pre-operatively (control group or non-intervention group).

Secondary outcome measures

Occurrence of post-cataract surgery CME in the non-intervention group (control group) detected by OCT.

Overall trial start date

01/01/2011

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Eyes receiving 0.005% Latanoprost at least 1-month prior to a planned phacoemulsification with PC-IOL implantation
2. Aged over 18 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. History of intra-ocular inflammation
2. Clinically significant macular edema (CSME), or macular oedema of any aetiology
3. Proliferative diabetic retinopathy
4. Retinitis pigmentosa
5. Prior vitreo-retinal surgery
6. Pregnancy
7. Known/suspicious allergy to non-steroidal anti-inflammatory drugs (NSAIDs)/prostaglandin analogues
8. Physical/mental/intellectual disabilities preventing from understanding and complying to protocol

Recruitment start date

01/01/2011

Recruitment end date

30/09/2011

Locations

Countries of recruitment

Thailand

Trial participating centre

Department of Ophthalmology
Bangkok
10330
Thailand

Sponsor information

Organisation

Chulalongkorn University (Thailand)

Sponsor details

Faculty of Medicine
1873 Rama 4 Road
Pathumwan
Bangkok
10330
Thailand
+66 (0)2 256 4963
apchula@hotmail.com

Sponsor type

Government

Website

http://161.200.98.10/english/index.php?option=com_frontpage&Itemid=1

Funders

Funder type

Charity

Funder name

Glaucoma Research Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

King Chulalongkorn Memorial Hospital (Thailand) - Department of Ophthalmology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes