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

8. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Bromfenac 0.09 % Ophthalmic Solution
Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.
Medicin: Bromfenac 0.09 % Ophthalmic Solution
Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
Eksperimentel: 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.
Medicin: Bromfenac 0.09 % Ophthalmic Solution
Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.
Medicin: Bromfenac 0.09 % Ophthalmic Solution
Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
Eksperimentel: 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.
Medicin: diclofenac 0.1% ophthalmic susp.
Diclofenac 0.1% ophthalmic solution administered four times daily for 4 weeks after cataract surgery.
Eksperimentel: 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.
Medicin: Nepafenac 0.1% eyedrops
Nepafenac 0.1% ophthalmic solution administered three times daily for 4 weeks after cataract surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pomeranian Medical University Szczecin

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. oktober 2020

Primær færdiggørelse (Faktiske)

22. maj 2024

Studieafslutning (Faktiske)

22. maj 2024

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MD-CATARACT-NSAID-2024

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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

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