To show non-inferiority in success rate of the lateral eyelid block excision compared to the lateral tarsal strip.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Complication rate (suture abscess/granuloma, exposed suture, point tenderness
over lateral orbital rim, and wound dehiscence). Surgery time.
Background summary
The lateral tarsal strip procedure is a successful and widely used technique to
correct horizontal eyelid laxity in, among others, ectropion, entropion, and
facial palsy. Lateral eyelid block excision is a less well known technique to
correct horizontal eyelid laxity with probably the same success rate but with
less complexity to perform.
Study objective
To show non-inferiority in success rate of the lateral eyelid block excision
compared to the lateral tarsal strip.
Study design
Randomized controlled non-inferiority trial with masking of the assessor of the
primary and secondary outcomes.
Intervention
Group 1: lateral tarsal strip procedure with permanent suture. Group 2: lateral
eyelid block excision with absorbable suture.
Study burden and risks
Both surgical procedures are accepted and practiced treatments to correct for
horizontal eyelid laxity. They bear the same, limited, risks of postoperative
bleeding, pain, inflammation and failure rate. The burden for patients related
to participation in the study is a more extensive physical examination,
informed consent procedure and questionnaires (10 minutes) and an extra one
year follow-up appointment (10 minutes, excluding travelling time). Because of
the non-inferiority design, there are no expected benefits in surgical
successes. However, benefits for the lateral eyelid block excision group are
anticipated in shorter surgery time and less suture-related complications.
Schiedamsevest 180
3011 BH Rotterdam
NL
Schiedamsevest 180
3011 BH Rotterdam
NL
Listed location countries
Age
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
Age under 18 years.
Surgical procedures that also include medial horizontal eyelid tightening.
Cicatricial diseases causing eyelid malposition
Cosmetic blepharoplasty
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24391.078.08 |