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
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.
Patients (cases) must meet ALL of the following criteria to be included in the study:
Exclusion Criteria:
Patients meeting ANY of the following criteria will not be eligible to participate in the study:
Procedure: Anterior white-line advancement using an ABSORBABLE suture (POLYSORB 5-0). RED CODE.
Procedure: Anterior 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 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.
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.
Margin Reflex Distance 1 (MRD1)
Time frame: 7 months postoperatively
Margin Reflex Distance 1 (MRD1)
Time frame: Basaline
Margin Reflex Distance 1 (MRD1)
Time frame: 2 weeks postoperatively
Margin Reflex Distance 1 (MRD1)
Time frame: 3 months postoperatively
Eyelid symmetry
Time frame: Basaline
Eyelid symmetry
Time frame: 2 weeks postoperatively
Eyelid symmetry
Time frame: 3 months postoperatively
Eyelid symmetry
Time frame: 7 months postoperatively
Ocular dominance
Time frame: Basaline
Hering's law dependence
Time frame: Basaline
Objective eyelid contour
Time frame: 2 weeks postoperatively
Objective eyelid contour
Time frame: 3 moths postoperatively
Objective eyelid contour
Time frame: 7 months postoperatively
Subjective eyelid contour
Time frame: 2 weeks postoperatively
Subjective eyelid contour
Time frame: 3 months postoperatively
Subjective eyelid contour
Time frame: 7 months postoperatively
Upper eyelid crease
Time frame: 2 weeks postoperatively
Upper eyelid crease
Time frame: 3 months postoperatively
Upper eyelid crease
Time frame: 7 months postoperatively
Clavien-Dindo Score
Time frame: Intervention day
Clavien-Dindo Score
Time frame: 2 weeks postoperatively
Clavien-Dindo Score
Time frame: 3 months postoperatively
Clavien-Dindo Score
Time frame: 7 months postoperatively
Reintervention
Time frame: 3 months postoperatively
Surgical success
Time frame: 7 months postoperatively
FACE-Q Upper Eyelid Assessment
Time frame: 3 months postoperatively
FACE-Q Upper Eyelid Assessment
Time frame: 7 months postoperatively
Plan to share: No
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz