Complications of preseptal versus retroseptal transconjunctival approach to isolated orbital wall fractures: A double-blind, non-inferiority, randomized, split-face controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240909001

Enrollment

177

Registered

2024-09-09

Start date

2015-04-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

The aim of this study was to evaluate the postoperative complications (PC) associated with preseptal transconjunctival approach (PS-TCA) and retroseptal transconjunctival approach (RS-TCA) in managing isolated orbital floor fractures (IOFF) through a randomized controlled trial design with an adequate sample size. The study tested the alternative hypothesis (H1) that PC of one TCA variant would be non-inferior to the other. The specific objectives were (1) to identify a cohort of patients with b

Interventions

preseptal transconjunctival approach to orbital floor fracture,postseptal transconjunctival approach to orbital floor fracture

Experimental Procedure/Surgery,Experimental Procedure/Surgery

PS TCA,RS TCA

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria required participants to be at least eighteen years of age, to be undergoing treatment for bilateral IOFF falling into Jaquiery et al's category I or II with a follow-up of at least six months, and to have an American Society of Anesthesiologists physical status class of one or two.

Exclusion criteria

Exclusion criteria: Subjects were excluded if they had pre-existing ocular/orbital diseases (e.g., chronic conjunctivitis or lacrimal system obstruction) or wound healing interference (e.g. uncontrolled diabetes mellitus), bleeding disorders, an ASA class 3-5, and fractures involving two or more orbital walls or in conjunction with other facial fractures, such as bilateral Le Fort II fractures or fractures of the infraorbital rim.

Design outcomes

Primary

Measure	Time frame
Entropion 6 months clinical observation,Ectropion 6 months clinical observation,Implant displacement 6 months clinical observation,Retrobulbar hematoma 6 months clinical observation,Infection 6 months clinical observation,Impaired ocular motility 6 months clinical observation,Enophthalmos 6 months clinical observation,Hypoglobus 6 months clinical observation	—

Secondary

Measure	Time frame
length of hospital stay at discharge days	—

Countries

Germany

Contacts

Public ContactPoramate Pitak Arnnop

MKG am Stift

poramate.pitak-arnnop@uk-gm.de00496421586864

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026