Anterior Versus Posterior Surgery for Eyelid Ptosis
Comparative Efficacy and Safety of Anterior Versus Posterior Levator Aponeurosis Advancement for Eyelid Ptosis Correction
The goal of this randomized clinical trial is to compare two surgical approaches for correcting drooping of the upper eyelid (aponeurotic ptosis) in adults who need surgery. This condition occurs when the tissue connecting the eyelid-lifting muscle to the eyelid becomes weakened or detached. It can affect one or both eyes.
The main questions this study aims to answer are:
- Does surgery performed through the inner surface of the eyelid (posterior approach) achieve an upper eyelid height at 6 months that is not meaningfully worse than surgery performed through the skin (anterior approach)?
- How do the two approaches compare in terms of complications, operating time, swelling, bruising, eyelid appearance, and patient satisfaction?
- How stable are the results during the 6 months after surgery?
Researchers will compare anterior and posterior approaches to levator aponeurosis advancement, a procedure that repositions and reattaches the tissue connecting the eyelid-lifting muscle to the eyelid. Both approaches are routinely used at Hospital Universitario 12 de Octubre in Madrid, Spain, where the study will take place.
Participants will be assigned by chance to one of the two surgical groups, with an equal chance of receiving either approach. All procedures will be performed under local anesthesia by the same experienced surgeon.
The main outcome is upper eyelid height 6 months after surgery, measured as the distance between the upper eyelid edge and the reflection of a light at the center of the pupil. The study will assess whether the posterior approach is no more than 0.5 millimeters worse than the anterior approach for this measurement. An independent healthcare professional will measure eyelid height and assess eyelid appearance.
Participants will:
- Attend a preoperative assessment, including an eye examination and measurements of eyelid position and movement.
- Undergo surgery using the randomly assigned approach.
- Attend follow-up visits the day after surgery, at 1 week, and at 1, 3, and 6 months.
- Have eyelid measurements and standardized photographs taken, and be assessed for swelling, bruising, and complications.
- Answer questions about their satisfaction with the appearance and function of their eyelids at 1, 3, and 6 months.
The visits and clinical assessments follow the hospital's usual care schedule for this surgery. Participation does not require additional visits or invasive tests beyond routine care.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Scientific Rationale
Anterior and posterior approaches to levator aponeurosis advancement differ in the tissues accessed and the surgical exposure required to restore eyelid position. The anterior approach provides access through the skin and orbicularis muscle, whereas the posterior approach accesses the levator aponeurosis through the conjunctival surface. These differences may influence surgical duration, tissue trauma, postoperative recovery, and cosmetic results.
Although both approaches are established surgical options, direct prospective randomized comparisons remain limited. Evidence supporting posterior advancement includes surgical case series, while the anterior approach remains widely used. A randomized comparison may help clarify whether the posterior approach preserves functional effectiveness while offering advantages in recovery or other aspects of the surgical outcome.
Study Hypothesis and Methodological Rationale
The study uses a noninferiority framework for its primary efficacy comparison. This framework addresses whether posterior advancement maintains an acceptable functional result relative to anterior advancement, rather than requiring it to produce a greater postoperative eyelid height. Potential advantages in operative duration, postoperative tissue response, safety, and patient experience will be examined separately through secondary comparisons.
The allocation sequence will be computer-generated using randomly varying block sizes of four and six. A study team member who is not involved in performing the operations will generate the sequence. Variable block sizes are intended to maintain balance between groups during recruitment while reducing the predictability of subsequent assignments.
Using one surgeon experienced in both techniques is intended to limit variation attributable to differences in surgical experience. The surgeon cannot be masked to the assigned approach. An independent healthcare professional will perform the principal efficacy measurements and cosmetic assessments.
Statistical Analysis
Descriptive analyses will characterize the study population and summarize the data. Continuous variables will be reported as means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be reported as frequencies and percentages. The distribution of continuous variables will be assessed using the Shapiro-Wilk test.
The primary comparison will use analysis of covariance, with postoperative upper eyelid height at the primary assessment as the dependent variable, surgical approach as the group factor, and the corresponding preoperative measurement as a covariate. The treatment difference will be calculated as posterior minus anterior approach. Noninferiority will be established if the lower bound of the two-sided 95% confidence interval for the adjusted mean difference is greater than -0.5 mm. This corresponds to a one-sided significance level of 0.025.
Secondary continuous variables will be compared using an independent-samples Student's t-test or the Mann-Whitney U test, according to their distribution. Categorical variables will be compared using the chi-square test or Fisher's exact test, as appropriate. Changes in eyelid height over follow-up will be examined using repeated-measures analysis of variance or a linear mixed-effects model. Secondary comparisons will use a significance threshold of 0.05.
The primary noninferiority conclusion will be considered separately from the secondary comparisons. Demonstrating noninferiority in eyelid height alone will not be interpreted as evidence of superiority in safety, recovery, or cosmetic outcomes.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Consuelo Mata Beltran, M.D.
- Telefonnummer: +34 609443271
- E-post: chelomata00@gmail.com
Studer Kontakt Backup
- Navn: Silvia Perez Trigo, M.D P.H.D
- Telefonnummer: +34 91 390 80 00
- E-post: consuelo.mata@salud.madrid.org
Studiesteder
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Madrid
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Madrid, Madrid, Spania, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
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Ta kontakt med:
- Consuelo Mata Beltran, Medical Doctor
- Telefonnummer: +34 609443271
- E-post: chelomata00@gmail.com
-
Ta kontakt med:
- Silvia Perez Trigo, Medical Doctor
- Telefonnummer: +34 91 390 80 00
- E-post: consuelo.mata@salud.madrid.org
-
Hovedetterforsker:
- Consuelo Mata Beltran, M.D.
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Underetterforsker:
- Silvia Perez Trigo, M.D. P.H.D.
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Underetterforsker:
- Regina Lopez-Ladron Garcia-Borbolla, M.D
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Underetterforsker:
- Alvaro Bengoa Gónzalez, M.D. P.H.D.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adults older than 18 years.
- Diagnosis of unilateral or bilateral aponeurotic ptosis caused by weakening or disinsertion of the levator aponeurosis.
- Clinical indication for surgical correction of ptosis.
- No previous ocular surgery.
- No other ophthalmic conditions that may affect eyelid anatomy.
- Provision of written informed consent.
Exclusion Criteria:
- Congenital, traumatic, neurogenic, myogenic, or mechanical ptosis.
- Previous eyelid surgery.
- Inability to provide informed consent or refusal to participate.
- Inability to cooperate with the surgical procedure under local anesthesia because of cognitive impairment or another disabling condition.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Anterior levator aponeurosis advancement
Participants assigned to this arm will undergo levator aponeurosis advancement and reattachment through an anterior (transcutaneous) approach, accessing the aponeurosis through the eyelid skin and orbicularis muscle. Surgery will be performed under local anesthesia by an experienced surgeon. This arm serves as the active comparator. Participants will receive routine postoperative care and follow-up for 6 months. |
Surgical correction of aponeurotic ptosis by advancement and reattachment of the levator aponeurosis through an anterior transcutaneous approach. The aponeurosis is accessed through the upper eyelid skin and orbicularis muscle to restore upper eyelid height. The procedure is performed under local anesthesia by a surgeon experienced in both study techniques. |
|
Eksperimentell: Posterior levator aponeurosis advancement
Participants assigned to this arm will undergo levator aponeurosis advancement and reattachment through a posterior (transconjunctival) approach, accessing the aponeurosis through the inner surface of the eyelid. Surgery will be performed under local anesthesia by the same experienced surgeon. This arm will be evaluated for noninferiority to the anterior approach. Participants will receive routine postoperative care and follow-up for 6 months. |
Surgical correction of aponeurotic ptosis by advancement and reattachment of the levator aponeurosis through a posterior transconjunctival approach (white-line advancement). The aponeurosis is accessed through the inner surface of the upper eyelid to restore upper eyelid height. The procedure is performed under local anesthesia by the same surgeon performing the anterior approach. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Margin Reflex Distance 1 (MRD1) at 6 Months After Surgery
Tidsramme: 6 months after surgery
|
Upper eyelid height assessed using margin reflex distance 1 (MRD1), defined as the vertical distance in millimeters between the upper eyelid margin and the corneal light reflex in primary gaze. Measurements will be performed by an independent healthcare professional. MRD1 at 6 months will be compared between the posterior and anterior levator aponeurosis advancement groups to assess noninferiority of the posterior approach. |
6 months after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Postoperative Complications
Tidsramme: Complications From surgery through 6 months after surgery
|
Number of participants experiencing at least one postoperative complication during the 6-month follow-up period. Complications include infection, bleeding, corneal abnormalities, and wound or suture dehiscence. The type of complication will also be recorded. The proportion of participants with complications will be compared between the two surgical groups. |
Complications From surgery through 6 months after surgery
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|
Surgical Duration
Tidsramme: During surgery
|
Duration of the surgical procedure, measured in minutes. For the anterior approach, surgical time is measured from the skin incision to the start of skin closure. For the posterior approach, surgical time is measured from the transconjunctival incision to placement of the final fixation suture. Surgical duration will be compared between groups. |
During surgery
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Postoperative Eyelid Edema Score
Tidsramme: 1 day and 1 week after surgery
|
Postoperative eyelid swelling assessed using the edema component of the Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE) scale, as specified in the study protocol. The four grades range from 1 (no coverage of the iris by swollen eyelids) to 4 (complete eye closure due to swelling). Higher scores indicate greater edema. Scores will be recorded separately for each assessed side and compared between surgical groups. |
1 day and 1 week after surgery
|
|
Postoperative Periorbital Ecchymosis Score
Tidsramme: 1 day and 1 week after surgery
|
Postoperative bruising assessed using the ecchymosis component of the Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE) scale, as specified in the study protocol. Scores range from 0 (no ecchymosis) to 3 (ecchymosis extending over more than two-thirds of the eyelid length). Higher scores indicate more extensive bruising. Scores will be recorded separately for each assessed side and compared between surgical groups. |
1 day and 1 week after surgery
|
|
Cosmetic Outcome Assessed by an Independent Healthcare Professional
Tidsramme: 1, 3, and 6 months after surgery
|
Postoperative eyelid appearance assessed by an independent healthcare professional using the study-specific cosmetic rating scale. Scores range from 0 to 10 and will be recorded at each scheduled cosmetic assessment. Cosmetic scores will be compared between the two surgical groups. |
1, 3, and 6 months after surgery
|
|
Patient Satisfaction With Surgical Outcomes
Tidsramme: 1, 3, and 6 months after surgery
|
Overall patient satisfaction with ptosis surgery assessed using the five-point question in the study-specific patient questionnaire. Responses are scored as 1 (very dissatisfied), 2 (dissatisfied), 3 (neutral), 4 (satisfied), or 5 (very satisfied). Higher scores indicate greater satisfaction. Participants may also select reasons for satisfaction or dissatisfaction, including appearance, eyelid function, and postoperative symptoms. Overall satisfaction scores will be compared between surgical groups. |
1, 3, and 6 months after surgery
|
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Change From Baseline in Margin Reflex Distance 1 (MRD1) at 6 Months
Tidsramme: Before surgery and 6 months after surgery
|
Change in upper eyelid height calculated as MRD1 at 6 months after surgery minus preoperative MRD1, measured in millimeters. MRD1 is the vertical distance between the upper eyelid margin and the corneal light reflex in primary gaze. A positive change indicates an increase in upper eyelid height relative to baseline. The change will be compared between the two surgical groups. |
Before surgery and 6 months after surgery
|
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Margin Reflex Distance 1 (MRD1) Over Follow-up
Tidsramme: 1 day, 1 week, 1 month, 3 months, and 6 months after surgery
|
Repeated measurements of margin reflex distance 1 (MRD1), in millimeters, used to assess the evolution and stability of upper eyelid position after surgery. MRD1 is the vertical distance between the upper eyelid margin and the corneal light reflex in primary gaze. Measurements obtained at each follow-up visit will be performed by an independent healthcare professional and compared between the posterior and anterior levator aponeurosis advancement groups. |
1 day, 1 week, 1 month, 3 months, and 6 months after surgery
|
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Palpebral Fissure Height
Tidsramme: Before surgery and at 1 day, 1 week, and 1, 3, and 6 months after surgery
|
Vertical distance between the upper and lower eyelid margins, measured in millimeters in primary gaze. Measurements will be obtained before surgery and at the scheduled postoperative visits to characterize changes in eyelid opening. Palpebral fissure height will be compared between the two surgical groups. |
Before surgery and at 1 day, 1 week, and 1, 3, and 6 months after surgery
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
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Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26/344
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
There is no current plan to share individual participant data. Study findings will be disseminated as aggregate results through peer-reviewed publications and scientific presentations.
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