A Study Comparing Sub-Tenon Steroid Injection Versus Eye Drops for Reducing Postoperative Inflammation After Cataract Surgery
Study Of The Safety And Efficacy Of Intraoperative Subtenon Triamcinolone Acetonide Injection Versus Topical Prednisolone Acetate 1% In Reducing Postoprerative Inflammation After Phacoemulsification
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Background: Postoperative ocular inflammation is a common physiological response following cataract surgery; however, excessive inflammation may compromise visual outcomes. Topical corticosteroids, particularly prednisolone acetate 1%, remain the standard treatment, but their use is limited by poor patient compliance and the need for frequent dosing. Sub-Tenon's corticosteroid injection offers a potential alternative with a prolonged anti-inflammatory effect.
Objective: To compare the safety and efficacy of a single sub-Tenon's injection of triamcinolone acetonide versus topical prednisolone acetate 1% in controlling postoperative inflammation after uncomplicated cataract surgery.
Methods: This prospective, randomized, interventional comparative study included 72 patients undergoing phacoemulsification surgery. Participants were randomly assigned into two groups: Group 1 received topical prednisolone acetate 1% according to a tapering regimen, while Group 2 received a single sub-Tenon's injection of triamcinolone acetonide (40 mg/mL).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Damascus, Syria
- University of Damascus, Faculty of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Patients eligible for senile cataract surgery meeting the following conditions:
Best-corrected visual acuity less than or equal to 0.5. Nuclear sclerosis grades NC1, NC2, NC3, or NC4 according to LOCS III, regardless of the grade of cortical or posterior subcapsular cataract.
Age 50 years and older.
Exclusion Criteria:
Patients with non-age-related cataracts (congenital, infantile, or drug-induced).
Patients with a history of previous intraocular surgery. Patients with any form of glaucoma. Patients with pseudoexfoliation syndrome. Patients with diabetes mellitus. Patients with uveitis. Patients scheduled for concurrent intraocular surgery at the time of cataract extraction (e.g., trabeculectomy or vitrectomy).
Patients using long-term topical ocular medications. Patients with only one functional eye. Patients with poor pupil dilation, defined as a pupil diameter of 5.5 mm or less, those requiring iris dilators, or those who experienced iris trauma during surgery.
Effective phacoemulsification time (EPT) exceeding 2 minutes. Patients who were non-compliant with follow-up visits. Patients who developed postoperative complications unrelated to the study treatment (such as endophthalmitis or intraocular lens dislocation).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intraoperative Subtenon Triamcinolone Acetonide
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Patients in this group received an intraoperative subtenon injection of triamcinolone acetonide at the end of phacoemulsification surgery.
The injection was administered to reduce postoperative inflammation.
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Aktiv komparator: Topical Prednisolone Acetate 1%
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Patients in this group received topical prednisolone acetate 1% eye drops postoperatively according to the standard regimen to control inflammation after phacoemulsification surgery.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Degree of postoperative ocular inflammation assessed by slit-lamp examination (cells and flare grading) after phacoemulsification surgery.
Tidsramme: 1day, 1week, 2week, 1month
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1day, 1week, 2week, 1month
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: sameh Kh issa, professor, University of Damascus, Faculty of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Damascus-Ophth.
Plan for individuelle deltakerdata (IPD)
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