|- candidate number||5247|
|- NTR Number||NTR1653|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-feb-2009|
|- Secondary IDs||2008-16/24391.078.08 OZR/NL |
|- Public Title||Lateral eyelid block excision versus lateral tarsal strip procedure.|
|- Scientific Title||Lateral eyelid block excision versus lateral tarsal strip procedure to correct for horizontal eyelid laxity; a randomized controlled non-inferiority trial.|
|- hypothesis||Lateral eyelid block excision is not inferior to lateral tarsal strip procedure.|
|- Healt Condition(s) or Problem(s) studied||Facial palsy, Entropion, Eyelid laxity, Ectropion|
|- 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||1. Age under 18 years;|
2. Surgical procedures that also include medial horizontal eyelid tightening;
3. Cicatricial diseases causing eyelid malposition;
4. Cosmetic blepharoplasty.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mrt-2009|
|- planned closingdate||31-mrt-2011|
|- Target number of participants||164|
|- Interventions||1. Lateral eyelid block excision;|
2. Lateral tarsal strip procedure.
|- 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||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.
|- Timepoints||Preoperative, peroperative, 2 months, 12 months.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. W.R. Bijlsma|
|- CONTACT for SCIENTIFIC QUERIES||Drs. W.R. Bijlsma|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Oogziekenhuis Rotterdam (OZR)|
(Source(s) of Monetary or Material Support)
|Stichting Wetenschappelijk Onderzoek het Oogziekenhuis|
|- Brief summary||Rationale: |
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.
To show non-inferiority in success rate of the lateral eyelid block excision compared to the lateral tarsal strip.
Randomized controlled non-inferiority trial with masking of the assessor of the primary and secondary outcomes.
Patients with horizontal eyelid laxity for which surgical intervention is planned in two tertiary referral centres in the Netherlands. Conditions with horizontal eyelid laxity include: entropion, ectropion, sagging secondary to an anophthalmic socket, facial palsy, and scleral show following blepharoplasty. Horizontal laxity is considered significant if there is an abnormal snap-back test and a malposition of the lower eyelid.
Group 1: lateral tarsal strip procedure with permanent suture. Group 2: lateral eyelid block excision with absorbable suture.
Main study parameters/endpoints:
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 study parameters: Complication rate (suture abscess/granuloma, exposed suture, point tenderness over lateral orbital rim, and wound dehiscence). Surgery time.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
|- Main changes (audit trail)|
|- RECORD||2-feb-2009 - 27-jan-2016|