Lateral eyelid block excision versus lateral tarsal strip procedure.

Lateral eyelid block excision versus lateral tarsal strip procedure to correct for horizontal eyelid laxity; a randomized controlled non-inferiority trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20295

Enrollment

164

Registered

2009-02-02

Start date

2009-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Ectropion Entropion Facial palsy Eyelid laxity due to ocular prosthesis wear

Interventions

1. Lateral eyelid block excision

2. Lateral tarsal strip procedure.

Eligibility

Inclusion criteria

Inclusion criteria: Patients who have an eyelid condition for which a surgical procedure is planned that includes lateral horizontal eyelid tightening. The conditions include: ectropion, entropion, facial palsy, eyelid laxity due to ocular prosthesis wear.

Exclusion criteria

Exclusion criteria: 1. Age under 18 years; 2. Surgical procedures that also include medial horizontal eyelid tightening; 3. Cicatricial diseases causing eyelid malposition; 4. Cosmetic blepharoplasty.

Design outcomes

Primary

Measure	Time frame
Surgical success at one year, defined as restoration of the lower eyelid position at the midline through the pupillary center and at the lateral canthus, without in- or outward rotation of the lower eyelid margin.	—

Secondary

Measure	Time frame
1. Horizontal eyelid laxity (snap-back test); 2. Complications, defined as any of suture abscess/granuloma, exposed suture, point tenderness or redness over lateral canthus persistent after two months, conjunctival inclusion cysts, and wound dehiscence; 3. Surgery time.	—

Contacts

Public ContactW.R. Bijlsma

w.r.bijlsma@umcutrecht.nl+31 (0)30 2509111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)