BlepharoptosisWhiteLine_SNCT07847749
Effect of Suture Material on Eyelid Height Stability After Anterior White-Line Advancement for Aponeurotic Ptosis.
A study testing 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 people with Blepharoptosis, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Blepharoptosis
- What is being tested?
- 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.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francisco Javier González García., MD, PhD. contact
Spain1 site
Rey Juan Carlos Hospital.
Móstoles, Madrid, 28932
Viviana Patricia Lezcano Carduz, MD, +34 914816225, viviana.lezcano@quironsalud.es
About this study
Official title: Influence of Suture Material on Postoperative Eyelid Height Stability Following Anterior White-Line Advancement for Primary Aponeurotic Ptosis: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- Anterior white-line advancement using an ABSORBABLE suture (POLYSORB 5-0). RED CODE., Anterior white-line advancement using a NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE.
- Keywords
- blepharoptosis, ptosis, White Line Advancement, aponeurotic ptosis
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior white-line advancement using an ABSORBABLE suture (POLYSORB 5-0). RED CODE.Procedure or surgery
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.
Anterior white-line advancement using a NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: ABSORBABLE suture (POLYSORB 5-0). RED CODE | Active comparator | Not described Receives: 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 | Not described Receives: Procedure: Anterior white-line advancement using a NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margin Reflex Distance 1 (MRD1)
Measured: 7 months postoperatively
Secondary outcomes (26)
Margin Reflex Distance 1 (MRD1)
Measured: Basaline
Margin Reflex Distance 1 (MRD1)
Measured: 2 weeks postoperatively
Margin Reflex Distance 1 (MRD1)
Measured: 3 months postoperatively
Eyelid symmetry
Measured: Basaline
Eyelid symmetry
Measured: 2 weeks postoperatively
Eyelid symmetry
Measured: 3 months postoperatively
Eyelid symmetry
Measured: 7 months postoperatively
Ocular dominance
Measured: Basaline
Hering's law dependence
Measured: Basaline
Objective eyelid contour
Measured: 2 weeks postoperatively
Objective eyelid contour
Measured: 3 moths postoperatively
Objective eyelid contour
Measured: 7 months postoperatively
Subjective eyelid contour
Measured: 2 weeks postoperatively
Subjective eyelid contour
Measured: 3 months postoperatively
Subjective eyelid contour
Measured: 7 months postoperatively
Upper eyelid crease
Measured: 2 weeks postoperatively
Upper eyelid crease
Measured: 3 months postoperatively
Upper eyelid crease
Measured: 7 months postoperatively
Clavien-Dindo Score
Measured: Intervention day
Clavien-Dindo Score
Measured: 2 weeks postoperatively
Clavien-Dindo Score
Measured: 3 months postoperatively
Clavien-Dindo Score
Measured: 7 months postoperatively
Reintervention
Measured: 3 months postoperatively
Surgical success
Measured: 7 months postoperatively
FACE-Q Upper Eyelid Assessment
Measured: 3 months postoperatively
FACE-Q Upper Eyelid Assessment
Measured: 7 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, parallel-group, single-center, participant-blinded clinical trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviana Patricia Lezcano Carduz, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Investigators
- Viviana Patricia Lezcano Carduz, MD, Principal investigator, Instituto de Investigación Sanitaria- Fundación JImenez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847749
- Sponsor's protocol ID
- EC105-26_HRJC
- Acronym
- WhiteLine_S
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Suture Material on Postoperative Eyelid Height Stability Following Anterior White-Line Advancement for Primary Aponeurotic Ptosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07847749
- Acronym / sponsor ID
- WhiteLine_S / EC105-26_HRJC
- Conditions
- Blepharoptosis
- Keywords
- blepharoptosis, ptosis, White Line Advancement, aponeurotic ptosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled, parallel-group, single-center, participant-blinded clinical trial.
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior 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. | Procedure or surgery | Group A: ABSORBABLE suture (POLYSORB 5-0). RED CODE |
| 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 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. | Procedure or surgery | Group B: NON-ABSORBABLE suture (POLYPROPYLENE 5-0). BLUE CODE |
Primary outcome
Margin Reflex Distance 1 (MRD1)
Time frame: 7 months postoperatively
26 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francisco Javier González García., MD, PhD. contact
Viviana Patricia Lezcano Carduz, MD principal investigator
Instituto de Investigación Sanitaria- Fundación JImenez Díaz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Blepharoptosis, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviana Patricia Lezcano Carduz, MD (+34 914816225, viviana.lezcano@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin Reflex Distance 1 (MRD1) (time frame: 7 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.