Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification

8. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

88

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Polen
      • Szczecin, Polen, 70-111
        • University Clinical Hospital No. 2, Pomeranian Medical University in Szczecin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Adults scheduled for elective uncomplicated phacoemulsification cataract surgery.
  2. Ability and willingness to provide written informed consent.
  3. No abnormalities detected on preoperative anterior segment examination.
  4. No abnormalities detected on preoperative posterior segment examination.
  5. 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:

  1. Systemic diseases that could affect the macula (e.g. diabetes).
  2. Topical or systemic medications that could affect the macula, e.g. chloroquine.
  3. Intraoperative complications.
  4. Coexisting ocular diseases.
  5. Previous ocular surgery.
  6. Patients who. for various reasons. declared unwillingness to attend follow-up visits 6 and 12 weeks after cataract surgery.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Bromfenac 0.09 % Ophthalmic Solution
Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.
Legemiddel: Bromfenac 0.09 % Ophthalmic Solution
Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
Eksperimentell: 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.
Legemiddel: Bromfenac 0.09 % Ophthalmic Solution
Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.
Legemiddel: Bromfenac 0.09 % Ophthalmic Solution
Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
Eksperimentell: 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.
Legemiddel: diclofenac 0.1% ophthalmic susp.
Diclofenac 0.1% ophthalmic solution administered four times daily for 4 weeks after cataract surgery.
Eksperimentell: 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.
Legemiddel: Nepafenac 0.1% eyedrops
Nepafenac 0.1% ophthalmic solution administered three times daily for 4 weeks after cataract surgery.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in Central Subfield Thickness After Cataract Surgery
Tidsramme: Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery
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.
Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation Between Central Subfield Thickness and Distance Best-Corrected Visual Acuity
Tidsramme: 6 weeks and 12 weeks after cataract surgery compare to baseline
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.
6 weeks and 12 weeks after cataract surgery compare to baseline
Central Subfield Thickness by Postoperative Distance Best-Corrected Visual Acuity Group
Tidsramme: 6 weeks and 12 weeks after cataract surgery
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.
6 weeks and 12 weeks after cataract surgery
Change in Central Subfield Thickness From Baseline
Tidsramme: Baseline, 6 weeks, and 12 weeks after cataract surgery
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.
Baseline, 6 weeks, and 12 weeks after cataract surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pomeranian Medical University Szczecin

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. oktober 2020

Primær fullføring (Faktiske)

22. mai 2024

Studiet fullført (Faktiske)

22. mai 2024

Datoer for studieregistrering

Først innsendt

1. juli 2026

Først innsendt som oppfylte QC-kriteriene

8. juli 2026

Først lagt ut (Faktiske)

10. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MD-CATARACT-NSAID-2024

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

A decision regarding the future sharing of individual participant data has not yet been made

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere