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Trial registered on ANZCTR


Registration number
ACTRN12609000732280
Ethics application status
Approved
Date submitted
21/08/2009
Date registered
25/08/2009
Date last updated
25/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of two techniques for transcutaneous lower eyelid blepharoplasty: A prospective surgical trial by using random allocation.
Scientific title
In patients with lower eyelid aging
are standard lower blepharoplasty and lower blepharoplasty with periorbital fat mobilization and arcus marginalis redrape effective in promoting the rejuvenation of the lower eyelid ?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aging lower eyelid 243567 0
lower eyelid laxity 243568 0
Condition category
Condition code
Surgery 239864 239864 0 0
Surgical techniques
Eye 239870 239870 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients submitted to lower eyelid blepharoplasty by two different techniques.
The Surgical Group 1 (SG1) consisted of standard fat-resection lower eyelid blepharoplasty.
The Surgical Group 2 (SG2) - Subciliary incision was drawn 3 mm below entire lash line, from the punctum medially to the lateral canthal region. The lateral aspect was made 4 to 5mm from lateral canthal angle within an existing crow’s foot. A small incision through skin and muscle was made with a blade at the lateral end of the marking, measuring approximately 10 mm. Straight iris scissors beveling away from the pretarsal orbicularis completed the subciliary skin incision, leaving the pretarsal orbicularis undisturbed. The preseptal orbicularis was opened from mid-pupil to the lateral orbital rim. The scissors were used to develop a plane between the septum and the preseptal orbicularis, then the skin muscle flap was raised, preserving approximately 6 mm of pretarsal orbicularis, exposing the retromuscular space. This flap was dissected to the level of the orbital rim using cutting eletrocautery, thereby the septum orbitale, the capsulopalpebral fascia, the inferior orbital rim, and arcus marginalis were exposed. The junction of the septum orbitale and the periosteum of the inferior orbital rim (arcus marginalis) was released using cutting eletrocautery. After placing a traction stitch to hold the lower lid in extesion, the complex formed by septum orbitale and capsulopalpebral fascia was elevated and the orbital fat from each of the three compartments was released, and conservastively removed or preserved and then repositioned. Only the orbital fat from the medial and central compartments were transposed and sutured to the periosteum with 6-0 Vicryl (registered trademark). The tear trough was corrected by release of the muscular origin contributing to the deformity, addition of volume by fat transposition, and tightening of the skin muscle flap. Next, the junction of the septum orbitale and the periosteum of the inferior orbital rim was reset to its anatomical position (simply suture back to the orbital rim) with interrupted 6-0 Vicryl (registered trademark).

Duration of procedure:
SG1- 1h 15m
SG2- 1h 25m
Intervention code [1] 241168 0
Treatment: Surgery
Comparator / control treatment
Patients were assigned to interventions into two surgical groups by using random allocation.
Surgical Group 1 (SG1) - patients submitted to conservatively standard fat-ressection lower blepharoplasty - Subciliary incision was drawn 3 mm below entire lash line, from the punctum medially to the lateral canthal region. The lateral aspect was made 4 to 5mm from lateral canthal angle within an existing crow’s foot. A small incision through skin and muscle was made with a blade at the lateral end of the marking, measuring approximately 10 mm. Straight iris scissors beveling away from the pretarsal orbicularis completed the subciliary skin incision, leaving the pretarsal orbicularis undisturbed. The preseptal orbicularis was opened from mid-pupil to the lateral orbital rim. The scissors were used to develop a plane between the septum and the preseptal orbicularis, then the skin muscle flap was raised, preserving approximately 6 mm of pretarsal orbicularis, exposing the retromuscular space. This flap was dissected to the level of the orbital rim using cutting eletrocautery. Intraoperatively, the volume of fat from each of the three compartments was assessed. The maneuver of gently balloting the globe with gentle pressure on the upper-eyelid skin was not performed to expose the orbital fat. Fat removal was performed conservatively using eletrocautery without excision of the septum.
Surgical Group 2 (SG2) - patients submitted to lower blepharoplasty with periorbital fat mobilization and arcus marginalis redrape.
In both techniques: elevation of the skin muscle flap was integral part of achieving the desired cosmetic result once the desired changes of the posterior lamella were performed. The anterior lamella was redraped in a superior lateral vector rather than a pure vertical vector. Excision of excess skin and muscle was done by removing a triangle of tissue lateral to the canthus, thereby minimizing the amount of tissue removed along the lid margin. The orbicularis muscle suspension was carried out by suturing the preseptal orbicularis muscle (attached to the lower skin flap) to the inferior aspect of the periosteum of the lateral orbital rim with a single stich of 6-0 Vicryl (registered trademark). A tension free closure was achieved with 6-0 nylon suture.
Duration of procedure:
SG1- 1h 15m
SG2- 1h 25m
Control group
Active

Outcomes
Primary outcome [1] 240646 0
To achieve some level of quantification of the results a graduated scale, as proposed by Barton et al, was used to grade the pre- and postoperative results, by having three independent observers examine pre- and postoperative standardized photographs, who had not been involved with the particular patients
Timepoint [1] 240646 0
baseline (pre-operatively);
post-operatively- between 6 months and 1 year after surgery.
Secondary outcome [1] 257280 0
compare lower lid laxity before and after canthopexy

Lower lid laxity was evaluated in all 50 patients by intraoperative lid distraction. The anterior lid distraction test refers to how much the lower eyelid can be manually pulled or distracted from apposition with the globe. The measurement was made with Castroviejo's caliper during the surgery, registering the values gotten before and after the canthopexy.
Lower lid redundancy (laxity) was also determined by grasping the lateral aspect of the lower lid, and tensing the lid in a horizontal direction while maintaining lid position just at the inferior limbus (lateral lid distraction test). The redundancy was defined as the distance from laterally displaced lateral commissure to the point where lower lid margin overlaps the lateral orbital rim edge.
Timepoint [1] 257280 0
before and immediately after surgery
Secondary outcome [2] 257299 0
analyzing the complication's rate

Clinical charts were reviewed by the authors to identify postoperative complications, including orbital hematoma, blepharitis, chemosis, lid malposition, and surgical revisions.
To achieve some level of quantification of the results a graduated scale, as proposed by Barton (Barton Jr FE, Ha R & Awada M (2004): Fat extrusion and septal reset in patients with the tear trough triad: a critical appraisal. Plast Reconstr Surg 113: 2115-2121.), was used to grade the pre- and postoperative results, by having three independent observers examine pre- and postoperative standardized photographs, who had not been involved with the particular patients.
Timepoint [2] 257299 0
baseline (pre-operatively);
post-operatively- between 6 months and 1 year after surgery.

Eligibility
Key inclusion criteria
Anyone between 30 to 65 years of age electing to undergo blepharoplasty, and who have passed the preoperative evaluation.
Preoperative evaluation included a thorough ophthalmologic history including previous ocular or periorbital surgery, history of dry eyes and/or visual disturbance, and any relevant medical conditions.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with history of previous injury or lower eyelid blepharoplasty were excluded from the present study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Determination of whether a patient would be treated in Surgical Group 1 or in Surgical Group 2 was based on random sampling numbers drawn up for each surgical group and were contained in a set of fifty sealed envelopes
(50 envelopes numbered consecutively from 1 through 50 were used as follows: 25 cards marked SG1 and other 25 cards marked SG2 were placed in each envelope by a physician not involved with this research and the researcher (surgeon) were blind as the type of surgery until moments before doing it. The envelopes were placed in an box and randomly taken before surgery.).
Any participant had an equal probability of assignment to the groups. After acceptance of a patient by the panel, and before admission to the operating room, the appropriate numbered envelope was opened by the surgeon; the card inside told if the patient was to be in Surgical Group 1 or in Surgical Group 2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Urn randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 1961 0
Brazil
State/province [1] 1961 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 237531 0
University
Name [1] 237531 0
Universidade Federal de Sao Paulo/Escola Paulista de Medicina (UNIFESP/EPM)
Country [1] 237531 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Sao Paulo/Escola Paulista de Medicina (UNIFESP/EPM)
Address
Rua Botucatu, 740 Sao Paulo/SP Brazil
ZIP 04023-900
Country
Brazil
Secondary sponsor category [1] 237005 0
None
Name [1] 237005 0
Address [1] 237005 0
Country [1] 237005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243661 0
Comite de Etica em Pesquisa (Human Subjects Review Board (Ethical Committee) at Federal University of Sao Paulo)
Ethics committee address [1] 243661 0
Ethics committee country [1] 243661 0
Brazil
Date submitted for ethics approval [1] 243661 0
10/11/2004
Approval date [1] 243661 0
21/01/2005
Ethics approval number [1] 243661 0
1/04/1468

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30080 0
Address 30080 0
Country 30080 0
Phone 30080 0
Fax 30080 0
Email 30080 0
Contact person for public queries
Name 13327 0
giovanni andre pires viana
Address 13327 0
al jauaperi 732
Sao Paulo/SP
zip 04523-013
Country 13327 0
Brazil
Phone 13327 0
+55 11 5055 3831
Fax 13327 0
+55 11 5055 3831
Email 13327 0
info@cliniplast.com
Contact person for scientific queries
Name 4255 0
giovanni andre pires viana
Address 4255 0
al jauaperi 732
Sao Paulo/SP
zip 04523-013
Country 4255 0
Brazil
Phone 4255 0
+55 11 5055 3831
Fax 4255 0
+55 11 5055 3831
Email 4255 0
info@cliniplast.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIResultados clínicos e satisfação dos pacientes após blefaroplastia inferior2011https://doi.org/10.1590/s0100-69912011000500006
Dimensions AIBlefaroplastia inferior: poderia a cirurgia proporcionar satisfação aos pacientes?2012https://doi.org/10.1590/s0004-27492012000600006
N.B. These documents automatically identified may not have been verified by the study sponsor.