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Use of Subconjunctival Epinephrine in Retinal Surgeries in order to ease fundus visualization throughout surgery

Efficacy of 0.1% Epinephrine Subconjunctival Injection versus Placebo in Intraoperative Mydriasis Maintenance during Vitrectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3qzhvg
Enrollment
Unknown
Registered
2018-08-01
Start date
2017-11-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Ophthalmopathies, mydriasis, vitrectomy, epinephrine, pupil disorders

Interventions

Experimental group: 45 patients with pars plana vitrectomy indication with pupils previously dilated with 3 tropicamide consecutive drops, will have the pupillary diameter measured with a millimeter s
Procedure/surgery
E04.540.960
C10.597.690
D02.033.100.291.310

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Lead Sponsor
Hospital Universitário Onofre Lopes da Universidade Federal do Rio Grande do Norte - HUOL/UFRN
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients submitted to isolated vitrectomy; Age of 18 or higher.

Exclusion criteria

Exclusion criteria: Pseudophakic patients with the cataract surgery performed in less than 6 months; History of uveitis; pseudoexfoliation; trauma; use of any systemic or topical anti-inflammatory medications within 2 weeks to surgery; Intraoperative complications; Patients submitted to scleral buckling or any anterior chamber procedure during vitrectomy.

Design outcomes

Primary

MeasureTime frame
Expected endpoint: Mean difference between pupil diameter measured at the end of the surgery of at least 1 mm larger in group epinephrine than placebo.;Endpoint found: Mean difference between pupil diameter measured at the end of the surgery of 1.1 mm larger in group epinephrine than placebo.

Secondary

MeasureTime frame
Expected endpoint: Difference of at least 1 mm between the end of surgery and before surgery pupillary diameter measurements.;Endpoint found: Difference of 0.6 and -0.3 mm between the end of surgery and before surgery pupillary diameter measurements in the experimental and control group, respectively.

Countries

Brazil

Contacts

Public ContactRafael de Araujo

Hospital Universitário Onofre Lopes da Universidade Federal do Rio Grande do Norte - HUOL/UFRN

barbosa.md@gmail.com+5584991213006

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 5, 2026