Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification
8 luglio 2026 aggiornato da: Pomeranian Medical University Szczecin
This randomized clinical study evaluated the effectiveness of different postoperative nonsteroidal anti-inflammatory drug (NSAID) regimens in patients undergoing uncomplicated phacoemulsification cataract surgery.
Eighty-eight eligible participants were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure: bromfenac 0.09% twice daily for 2 weeks, bromfenac 0.09% twice daily for 4 weeks, diclofenac 0.1% four times daily for 4 weeks, or nepafenac 0.1% three times daily for 4 weeks.
All patients received the same standard perioperative care and adjunctive dexamethasone treatment.
The primary outcome was central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT) at 6 and 12 weeks after surgery.
Secondary outcomes included best-corrected distance visual acuity, refraction, and intraocular pressure.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
Cystoid macular edema remains one of the most important causes of suboptimal visual outcomes after cataract surgery. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to reduce postoperative inflammation and the risk of macular thickening; however, the optimal NSAID regimen remains uncertain.
This prospective randomized clinical study was designed to compare the effectiveness of different postoperative NSAID regimens following uncomplicated phacoemulsification cataract surgery. Eligible patients scheduled for elective cataract surgery were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure. Participants underwent ophthalmic examinations before surgery and at 6 and 12 weeks after surgery.
The primary objective was to evaluate changes in central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT). Secondary assessments included best-corrected distance visual acuity, refraction, and intraocular pressure. All participants received standard perioperative care, and postoperative treatment was administered according to the assigned study regimen.
The study was approved by the Bioethics Committee of the Pomeranian Medical University in Szczecin, and all participants provided written informed consent before enrollment.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
88
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Szczecin, Polonia, 70-111
- University Clinical Hospital No. 2, Pomeranian Medical University in Szczecin
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Adults scheduled for elective uncomplicated phacoemulsification cataract surgery.
- Ability and willingness to provide written informed consent.
- No abnormalities detected on preoperative anterior segment examination.
- No abnormalities detected on preoperative posterior segment examination.
- Willingness and ability to attend follow-up visits at 6 and 12 weeks after cataract surgery.
Exclusion Criteria:
The exclusion criteria for the study were:
- Systemic diseases that could affect the macula (e.g. diabetes).
- Topical or systemic medications that could affect the macula, e.g. chloroquine.
- Intraoperative complications.
- Coexisting ocular diseases.
- Previous ocular surgery.
- Patients who. for various reasons. declared unwillingness to attend follow-up visits 6 and 12 weeks after cataract surgery.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Arm 1 Bromfenac 0.09% for 2 Weeks
Arm 1 - Bromfenac 0.09% for 2 Weeks Participants received bromfenac 0.09% ophthalmic solution twice daily for 2 weeks following uncomplicated phacoemulsification cataract surgery.
All participants also received standard perioperative care and postoperative dexamethasone treatment.
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Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.
Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
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Sperimentale: Arm 2 Bromfenac 0.09% for 4 Weeks
Arm 2 - Bromfenac 0.09% for 4 Weeks Participants received bromfenac 0.09% ophthalmic solution twice daily for 4 weeks following uncomplicated phacoemulsification cataract surgery.
All participants also received standard perioperative care and postoperative dexamethasone treatment.
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Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.
Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
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Sperimentale: Arm 3 - Diclofenac 0.1% for 4 Weeks
Arm 3 - Diclofenac 0.1% for 4 Weeks Participants received diclofenac 0.1% ophthalmic solution four times daily for 4 weeks following uncomplicated phacoemulsification cataract surgery.
All participants also received standard perioperative care and postoperative dexamethasone treatment.
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Diclofenac 0.1% ophthalmic solution administered four times daily for 4 weeks after cataract surgery.
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Sperimentale: Arm 4 - Nepafenac 0.1% for 4 Weeks
Arm 4 - Nepafenac 0.1% for 4 Weeks Participants received nepafenac 0.1% ophthalmic solution three times daily for 4 weeks following uncomplicated phacoemulsification cataract surgery.
All participants also received standard perioperative care and postoperative dexamethasone treatment.
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Nepafenac 0.1% ophthalmic solution administered three times daily for 4 weeks after cataract surgery.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes in Central Subfield Thickness After Cataract Surgery
Lasso di tempo: Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery
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Central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), to compare postoperative macular thickness among treatment groups receiving different topical nonsteroidal anti-inflammatory drug (NSAID) regimens following uncomplicated cataract surgery.
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Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Correlation Between Central Subfield Thickness and Distance Best-Corrected Visual Acuity
Lasso di tempo: 6 weeks and 12 weeks after cataract surgery compare to baseline
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Correlation between central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), and distance best-corrected visual acuity (DBCVA), reported as decimal visual acuity, measured using a Snellen chart, at 6 and 12 weeks after uncomplicated cataract surgery.
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6 weeks and 12 weeks after cataract surgery compare to baseline
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Central Subfield Thickness by Postoperative Distance Best-Corrected Visual Acuity Group
Lasso di tempo: 6 weeks and 12 weeks after cataract surgery
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Central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), compared between eyes with postoperative distance best-corrected visual acuity (DBCVA) <0.9 and eyes with postoperative DBCVA of 0.9-1.0,
measured using a Snellen chart and reported as decimal visual acuity, at 6 and 12 weeks after uncomplicated cataract surgery.
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6 weeks and 12 weeks after cataract surgery
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Change in Central Subfield Thickness From Baseline
Lasso di tempo: Baseline, 6 weeks, and 12 weeks after cataract surgery
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Change in central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), from baseline (preoperative assessment) to 6 and 12 weeks after uncomplicated cataract surgery in all study participants, regardless of the assigned topical nonsteroidal anti-inflammatory drug (NSAID) regimen.
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Baseline, 6 weeks, and 12 weeks after cataract surgery
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
14 ottobre 2020
Completamento primario (Effettivo)
22 maggio 2024
Completamento dello studio (Effettivo)
22 maggio 2024
Date di iscrizione allo studio
Primo inviato
1 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
8 luglio 2026
Primo Inserito (Effettivo)
10 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 luglio 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie degli occhi
- Malattie della lente
- Cataratta
- Soluzioni farmaceutiche
- Prodotti chimici organici
- Preparati farmaceutici
- Azioni farmacologiche
- Azioni e usi chimici
- Usi terapeutici
- Acidi carbossilici
- Soluzioni
- Usi speciali di sostanze chimiche
- Acidi, carbociclico
- Fenilacetati
- Soluzioni oftalmiche
- Diclofenac
- nepafenac
- Bromfenac
Altri numeri di identificazione dello studio
- MD-CATARACT-NSAID-2024
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
A decision regarding the future sharing of individual participant data has not yet been made
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .