Effect of Suture Material on Eyelid Height Stability After Anterior White-Line Advancement for Aponeurotic Ptosis.

NCT07847749 | Not Yet Recruiting

• 1 other identifier: EC105-26_HRJC
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

What is the diagnosis and what treatment is indicated? The 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 the present case, the indicated procedure consists of reinserting the tendon of the upper eyelid levator muscle into the 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 that participants will 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 type could be used regardless of participation 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 the outcomes associated with each type of suture in the medium and long term. How will the type of suture be determined? If a participant agrees to participate, the type of suture used during surgery will be assigned randomly by a computerized randomization system. Neither the participant nor 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. Participants will not be informed which type of suture was used during 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. The procedure 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 a particular 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 without participation 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 a participant decides to participate, the participant will be asked to sign an Informed Consent Form. Participation will involve allowing information from the 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.

Conditions

Blepharoptosis

Keywords

blepharoptosis; ptosis; White Line Advancement; aponeurotic ptosis

Outcome Measures

Primary Outcomes (1)

• Margin Reflex Distance 1 (MRD1)

  7 months postoperatively

Secondary Outcomes (26)

• Margin Reflex Distance 1 (MRD1)

  Basaline

• Margin Reflex Distance 1 (MRD1)

  2 weeks postoperatively

• Margin Reflex Distance 1 (MRD1)

  3 months postoperatively

• Eyelid symmetry

  Basaline

• Eyelid symmetry

  2 weeks postoperatively

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Interventions

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

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.

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

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

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.

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Rey Juan Carlos Hospital.

Móstoles, Madrid, 28932, Spain

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Viviana Patricia Lezcano Carduz, MD

  Instituto de Investigación Sanitaria- Fundación JImenez Díaz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviana Patricia Lezcano Carduz, MD

CONTACT

+34 914816225; viviana.lezcano@quironsalud.es

Francisco Javier González García., MD, PhD.

CONTACT

+34 914816225; Fjavier.gonzalez@hospitalreyjuancarlos.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor. Ophthalmologist.

Model Details: Randomized, controlled, parallel-group, single-center, participant-blinded clinical trial.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)