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Not yet recruitingNCT07847749WhiteLine_SUpdated Sep 29, 2026

Effect of Suture Material on Eyelid Height Stability After Anterior White-Line Advancement for Aponeurotic Ptosis: A Randomized Controlled Trial.

An interventional study of Anterior white-line advancement using an ABSORBABLE suture (POLYSORB 5-0). RED CODE. and Anterior white-line advancement using a NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE. in Blepharoptosis, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Not yet recruiting at 1 site in Spain. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

What is my diagnosis and what treatment is indicated in my case? Your diagnosis is "eyelid ptosis", which means drooping of the upper eyelid. This may reduce quality of life by affecting the upper visual field and interfering with daily activities such as driving and reading. It may also cause forehead muscle fatigue, neck pain, a sad or tired appearance, eyelid asymmetry, and forehead wrinkles.

The only treatment to correct eyelid ptosis is surgery. In your case, the indicated procedure consists of reinserting the tendon of the upper eyelid levator muscle into its original position on the tarsus. This is performed using sutures to attach the tendon to the tarsus. Two types of sutures may be used: absorbable sutures, which are absorbed by the body over approximately 2-3 months, and non-absorbable sutures, which remain permanently in the eyelid because the body cannot break them down.

Why is this study being conducted? The surgery you are going to undergo is part of the standard treatment for eyelid ptosis. Both types of suture material used in this procedure are routinely used in clinical practice, meaning that either could be used even if you did not participate in the study.

Some previous studies suggest that non-absorbable sutures may maintain eyelid elevation better in the long term and reduce the need for further surgery compared with absorbable sutures. However, there is currently insufficient evidence to establish this with certainty. Most previous studies have evaluated patients who had already been treated rather than prospectively comparing both types of sutures through a randomized clinical trial, which may introduce bias when interpreting the results.

Therefore, there is currently insufficient scientific evidence to determine with certainty which suture material provides better results, and both materials continue to be routinely used in clinical practice.

The aim of this study is to compare both types of suture under controlled conditions through a randomized controlled trial, in order to determine their outcomes in the medium and long term.

How will the type of suture I receive be determined? If you agree to participate, the type of suture used during surgery will be assigned randomly by a computerized randomization system. Neither you or the surgeon will be able to choose the type of suture.

Both suture materials are routinely used in clinical practice and are authorized for this type of surgery. The only difference between the two study groups will be the material used to attach the upper eyelid levator tendon to the tarsus.

You will not be informed which type of suture was used during your surgery, although this information may be accessed if medically necessary.

What does the procedure involve? The surgery will be performed in an operating room by ophthalmologists specialized in eyelid surgery. It will be performed under local anesthesia with light sedation. This is an outpatient procedure and does not require hospital admission. The procedure lasts approximately 45-60 minutes. If removal of excess skin is required in your case, this will be performed during the same procedure.

Anterior white-line (levator tendon) advancement through the skin produces a scar within the eyelid crease. This is generally a cosmetic and well-tolerated scar.

Five visits will be required for appropriate follow-up, which is the same number of visits that would be required if you did not participate in the study: the initial visit, the day of surgery, and three follow-up visits at **2 weeks, 3 months, and 7 months**. Participation in this study does not involve any additional risk from supplementary tests.

During the study, photographs of the periocular area and face will be taken to evaluate the surgical outcomes. These images will be treated as personal health data.

If you decide to participate, you will be asked to sign an Informed Consent Form. Your participation will involve allowing information from your medical record to be collected, consenting to relevant clinical photographs, and attending the scheduled follow-up visits.

The study will be conducted at Hospital Rey Juan Carlos and aims to include 58 patients with the same condition as yours.

02

Conditions studied

  • Blepharoptosis

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Keywords

  • blepharoptosis
  • ptosis
  • White Line Advancement
  • aponeurotic ptosis
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients (cases) must meet ALL of the following criteria to be included in the study:

  • Age >18 years.
  • Diagnosis of primary aponeurotic eyelid ptosis.
  • Upper eyelid levator muscle function of ≥12 mm.
  • Acceptance and signing of informed consent to participate in the study after having received adequate information.

Exclusion criteria

Exclusion Criteria:

Patients meeting ANY of the following criteria will not be eligible to participate in the study:

  • Diagnosis of eyelid ptosis of non-aponeurotic etiology.
  • Diagnosis of recurrent eyelid ptosis or previous surgical treatment for ptosis.
  • Known allergy or previous adverse reaction to any of the suture materials under investigation.
  • Medical or surgical history that, in the investigator's judgment, precludes participation in the study.
  • Participant with reproductive potential who is not using highly effective contraception.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
58 participants (estimated)

Study arms

  • Active comparator
    Group A: ABSORBABLE suture (POLYSORB 5-0). RED CODE

    Procedure: Anterior white-line advancement using an ABSORBABLE suture (POLYSORB 5-0). RED CODE.

  • Experimental
    Group B: NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE

    Procedure: Anterior white-line advancement using a NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE.

Interventions

  • ProcedureAnterior white-line advancement using an ABSORBABLE suture (POLYSORB 5-0). RED CODE.

    A traction suture is placed in the gray line. A skin incision is made at the upper eyelid crease using a Colorado-tip electrocautery device. Dissection is performed through the orbicularis muscle to expose the superior tarsal border and approximately 2 mm of its anterior surface. Proximal dissection is then performed in the pre-Müller's muscle-conjunctiva plane to identify the white line. A double-armed, non-transfixing, absorbable POLYSORB 5-0 suture is placed through the anterior tarsus (1 mm from its superior border) and the exposed white line at the pupillary axis. The suture is temporarily tied to assess eyelid height and contour and then permanently tied once adequate positioning is confirmed. The skin is closed with a 6-0 non-absorbable monofilament suture.

  • ProcedureAnterior white-line advancement using a NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE.

    A traction suture is placed in the gray line. A skin incision is made at the upper eyelid crease using a Colorado-tip electrocautery device. Dissection is performed through the orbicularis muscle to expose the superior tarsal border and approximately 2 mm of its anterior surface. Proximal dissection is then performed in the pre-Müller's muscle-conjunctiva plane to identify the white line. A double-armed, non-transfixing, absorbable POLYPROPYLENE 5-0 suture is placed through the anterior tarsus (1 mm from its superior border) and the exposed white line at the pupillary axis. The suture is temporarily tied to assess eyelid height and contour and then permanently tied once adequate positioning is confirmed. The skin is closed with a 6-0 non-absorbable monofilament suture.

05

What researchers measure

Primary outcomes

  1. Margin Reflex Distance 1 (MRD1)

    Time frame: 7 months postoperatively

Secondary outcomes

  1. Margin Reflex Distance 1 (MRD1)

    Time frame: Basaline

  2. Margin Reflex Distance 1 (MRD1)

    Time frame: 2 weeks postoperatively

  3. Margin Reflex Distance 1 (MRD1)

    Time frame: 3 months postoperatively

  4. Eyelid symmetry

    Time frame: Basaline

  5. Eyelid symmetry

    Time frame: 2 weeks postoperatively

  6. Eyelid symmetry

    Time frame: 3 months postoperatively

  7. Eyelid symmetry

    Time frame: 7 months postoperatively

  8. Ocular dominance

    Time frame: Basaline

  9. Hering's law dependence

    Time frame: Basaline

  10. Objective eyelid contour

    Time frame: 2 weeks postoperatively

  11. Objective eyelid contour

    Time frame: 3 moths postoperatively

  12. Objective eyelid contour

    Time frame: 7 months postoperatively

  13. Subjective eyelid contour

    Time frame: 2 weeks postoperatively

  14. Subjective eyelid contour

    Time frame: 3 months postoperatively

  15. Subjective eyelid contour

    Time frame: 7 months postoperatively

  16. Upper eyelid crease

    Time frame: 2 weeks postoperatively

  17. Upper eyelid crease

    Time frame: 3 months postoperatively

  18. Upper eyelid crease

    Time frame: 7 months postoperatively

  19. Clavien-Dindo Score

    Time frame: Intervention day

  20. Clavien-Dindo Score

    Time frame: 2 weeks postoperatively

  21. Clavien-Dindo Score

    Time frame: 3 months postoperatively

  22. Clavien-Dindo Score

    Time frame: 7 months postoperatively

  23. Reintervention

    Time frame: 3 months postoperatively

  24. Surgical success

    Time frame: 7 months postoperatively

  25. FACE-Q Upper Eyelid Assessment

    Time frame: 3 months postoperatively

  26. FACE-Q Upper Eyelid Assessment

    Time frame: 7 months postoperatively

06

Study locations

1 site
  • Rey Juan Carlos Hospital.
    Móstoles, Madrid 28932, Spain
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07847749
Lead sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Responsible party
Viviana Patricia Lezcano Carduz (Medical Doctor. Ophthalmologist., Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz) — Principal investigator
First posted
Sep 29, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2028 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Viviana Patricia Lezcano Carduz, MD
Contact
viviana.lezcano@quironsalud.es
+34 914816225
Francisco Javier González García., MD, PhD.
Contact
Fjavier.gonzalez@hospitalreyjuancarlos.es
+34 914816225
Viviana Patricia Lezcano Carduz, MD
principal investigator · Instituto de Investigación Sanitaria- Fundación JImenez Díaz

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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