Nepafenac and prevention of cystoid macular edema (CME) after cataract surgery in patients receiving latanoprost
| ISRCTN | ISRCTN38025852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38025852 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/12/2010
- Registration date
- 22/12/2010
- Last edited
- 22/12/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Supawat Trepatchayakorn
Scientific
Scientific
Department of Ophthalmology
Faculty of Medicine
Chulalongkorn University
1873 Rama 4 Road
Pathumwan
Bangkok
10330
Thailand
Study information
| Study design | Randomised double-masked controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| 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 | Nepafenac and prevention of cystoid macular edema (CME) after cataract surgery in patients receiving latanoprost: a randomised controlled trial |
| Study objectives | 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(s) | Institutional Review Board, Faculty of Medicine, Chulalongkorn University, approved on the 14th October 2010 (ref: COA no.514/2010 IRB no.241/53) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Nepafenac, latanoprost |
| Primary outcome measure | 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 study start date | 01/01/2011 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Department of Ophthalmology
Bangkok
10330
Thailand
10330
Thailand
Sponsor information
Chulalongkorn University (Thailand)
Government
Government
Faculty of Medicine
1873 Rama 4 Road
Pathumwan
Bangkok
10330
Thailand
| Phone | +66 (0)2 256 4963 |
|---|---|
| apchula@hotmail.com | |
| Website | http://161.200.98.10/english/index.php?option=com_frontpage&Itemid=1 |
"ROR" |
https://ror.org/028wp3y58 |
Funders
Funder type
Charity
Glaucoma Research Fund (UK)
No information available
King Chulalongkorn Memorial Hospital (Thailand) - Department of Ophthalmology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
