Nepafenac and Prevention of CME after Cataract Surgery in Patients Receiving Latanoprost: A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20110000013

Enrollment

Registered

2011-05-06

Start date

2010-12-24

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Cystoid macular oedema CME Cystoid macular oedema Prostaglandin Latanoprost Nepafenac NSAIDs Cataract surgery Phacoemulsification OCT Optical coherence tomography

Interventions

Only eyes received 0.005% Latanoprost at least 1&#45

month prior to a planned phacoemulsification with PC&#45

IOL implantation&#44

would be included&#44

as indicated in the inclusion criteria. Subjects that were met with inclusion and exclusion criteria will be randomly assigned using block&#45

of&#45

six. Group 1: 0.005% Latanoprost ed 0.005% Latanoprost and Latanoprost placebo are masked and given once daily before bedtime&#44

starting from the first day after cataract surgery until the study endpoint at the 10th post&#45

operative week. All subjects undergo a clear corneal incision&#44

phacoemulsification&#44

and intraocular lens implantation using an acrylic foldable IOL (AcrysofIQ

Alcon Inc.&#44

Fort Worth&#44

Tx&#44

USA). Post&#45

operative regimen includes 0.5% Moxifloxacin (Vigamox

USA) given qid for 1 month&#44

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Eyes receiving 0.005% Latanoprost at least 1-month prior to a planned phacoemulsification with PC-IOL implantation; age over 18 years

Exclusion criteria

Exclusion criteria: history of intra-ocular inflammation; CSME, or macular oedema of any aetiology; proliferative diabetic retinopathy; retinitis pigmentosa; prior vitreo-retinal surgery; pregnancy; known/suspicious allergy to NSAIDs/Prostaglandin analogues; physical/mental/intellectual disabilities preventing from understanding and complying to protocol

Design outcomes

Primary

Measure	Time frame
Incidence of post-operative CME Up to 10 weeks accumulatively post-operative Optical Coherence Tomography	—

Secondary

Measure	Time frame
Occurrence of post-cataract surgery CME in non-intervention group Up to 10 weeks accumulatively post-operative Optical Coherence Tomography	—

Countries

Thailand

Contacts

Public ContactSupawat Trepatchayakorn

King Chulalongkorn Memorial Hospital

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026