An interventional study of Levator resection with levator muscle scraping and Levator resection without scraping in Ptosis, Eyelid, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 32 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Zagazig University · Not applicable, Interventional, and Treatment
Congenital ptosis is drooping of the upper eyelid present from birth that can affect vision and appearance. When the eyelid muscle function is good, the eyelid can be corrected by plication (folding and tightening) of the levator muscle that lifts the eyelid.
The main problem with plication is that the eyelid may droop again over time because the smooth muscle surface does not form a strong adhesion. Scraping the muscle surface to create a raw surface may cause scar tissue and stronger adhesion, leading to more stable results.
This randomized study included 50 patients (27 males, 23 females, aged 6 to 32 years) with unilateral congenital ptosis and good levator function greater than 10 mm. Patients were randomly assigned by computer to two groups of 25 patients each. Group A received anterior approach levator plication with scraping of the levator muscle surface using a No. 15 blade until loss of luster and bleeding. Group B received the same plication without scraping. In both groups, three horizontal mattress sutures using 5-0 Ethibond non-absorbable polyester were used.
Eyelid height (Marginal Reflex Distance 1) and patient satisfaction were measured at 1 week, 4 weeks, 12 weeks, and 24 weeks after surgery. The study aims to determine if scraping leads to more consistent and permanent eyelid height.
This is a retrospective registration of a completed study conducted at Zagazig University Hospitals, Egypt, approved by the Institutional Review Board.
BACKGROUND: Drooping of the upper eyelid is called ptosis. Congenital ptosis can cause visual, functional, and cosmetic problems. Surgical correction is recommended. The choice of surgery depends on levator muscle function. For mild to moderate ptosis with fair to good levator function, levator resection is considered gold standard, but levator plication has become popular because it is simple, requires less dissection, is reversible, and preserves natural lid physiology. However, plication has higher recurrence rate due to lack of strong adhesion between smooth aponeurosis surfaces, especially when absorbable sutures are used.
RATIONALE FOR SCRAPING: Scraping of muscle surface until bleeding causes direct muscle injury, creation of raw surface, leading to scar formation, fibrosis, and adhesions, which may cause more permanent results.
OBJECTIVE: To evaluate and compare the effectiveness of anterior approach levator plication for congenital ptosis correction with versus without scraping of the levator muscle surface.
STUDY DESIGN: Prospective, comparative, interventional, randomized clinical trial conducted in clinical practice at Department of Ophthalmology, Zagazig University Hospitals.
PARTICIPANTS: 50 patients with unilateral congenital ptosis (one eye), 27 males and 23 females, age range 6-32 years (mean Group A 15.88±7.7, Group B 13.96±6.9). Inclusion: unilateral congenital ptosis, strong levator function >10mm (classification: poor \<4mm, moderate 5-8mm, good 9-12mm, excellent >12mm). Exclusion: age \<6 years, bilateral ptosis, fair 5-7mm or poor ≤4mm levator function, acquired ptosis, poor Bell's phenomenon, other developmental lid abnormalities, history of prior lid surgery. All patients or guardians gave written informed consent including consent for photography.
RANDOMIZATION: Computer-generated randomization table into two equal groups: Group A (n=25) with scraping, Group B (n=25) without scraping.
SURGICAL TECHNIQUE: All procedures under general anesthesia. Eyelid crease marked. Skin incision, suborbicularis dissection, orbital septum identified and opened, levator aponeurosis exposed. In Group A, scraping performed with blade 15, area slightly larger than plication by 2mm, endpoint loss of luster and appearance of bleeding. Three horizontal mattress sutures with 5-0 Ethibond polyester non-absorbable suture placed at level determined by ptosis degree and levator function (Berke 1959 technique), one in middle above mid-pupil, one medial, one lateral. Three lid crease-forming sutures placed, skin closed with interrupted 6-0 polypropylene. Reverse Frost suture and dressing applied. Postoperative: topical antibiotics, lubricating drops and nighttime ointment, systemic antibiotics and steroids for edema, cold compresses. Sutures removed at 10 days. Postoperative follow-up at day 1, weeks 1, 2, 4, 12, 24.
STATISTICAL ANALYSIS: SPSS v20. Mean±SD, Mann-Whitney, independent t-test, Friedman's ANOVA for repeated measures, Chi-square, p\<0.05 significant.
75 studies on the registry are indexed under Blepharoptosis; 14 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 56 interventional studies indexed under Blepharoptosis.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anterior approach levator plication with scraping of levator muscle surface. Under general anesthesia, eyelid crease incision, suborbicularis dissection, orbital septum opened, levator aponeurosis exposed. Scraping performed with scalpel blade No.15 over area 2mm larger than planned plication, endpoint loss of luster of aponeurosis and appearance of bleeding. Plication with three horizontal mattress sutures using 5-0 Ethibond non-absorbable polyester, placed at level determined by ptosis degree and levator function per Berke 1959, one mid-pupillary, one medial, one lateral. Three lid crease sutures, skin closure with interrupted 6-0 polypropylene. Reverse Frost suture and dressing. Postop topical antibiotics, lubricants, systemic antibiotics and steroids, cold compresses. Sutures removed day 10. Follow-up day 1, weeks 1,2,4,12,24.
Procedure: Levator resection with levator muscle scraping
Anterior approach levator plication without scraping of levator muscle surface. Same surgical technique as experimental arm under general anesthesia, eyelid crease incision, dissection to levator aponeurosis, but without any scraping of aponeurosis. Plication performed with three horizontal mattress sutures using 5-0 Ethibond non-absorbable polyester, placement per Berke 1959. Three lid crease sutures, skin closure with 6-0 polypropylene, reverse Frost suture, dressing. Same postoperative regimen: topical antibiotics, lubricants, systemic antibiotics/steroids, cold compresses. Suture removal day 10, same follow-up schedule at day 1, weeks 1,2,4,12,24.
Procedure: Levator resection without scraping
Levator aponeurosis muscle scraping off anterior surface of tarsal plate followed by levator resection. Under general anesthesia, eyelid crease incision, orbicularis opened, levator aponeurosis identified, scraped off tarsus using blunt dissector, then resected and advanced and fixed to tarsus with 3 interrupted 6-0 vicryl sutures to achieve desired lid height. Intraoperative adjustment for MRD1 4-5mm.
Levator resection without scraping of levator muscle off tarsus. Under general anesthesia, eyelid crease incision, orbicularis opened, levator aponeurosis identified without scraping, resected and advanced and fixed to tarsus with 3 interrupted 6-0 vicryl sutures to achieve desired lid height. Intraoperative adjustment for MRD1 4-5mm.
Change in Marginal Reflex Distance 1 (MRD1)
MRD1 measured in millimeters using standard ruler with patient in primary gaze, fixating at distant light source. Measured as distance from central corneal light reflex to upper eyelid margin. Measured preoperatively and postoperatively. Improvement calculated as postoperative MRD1 minus preoperative MRD1. Measured by blinded outcomes assessor.
Time frame: Preoperative baseline, and at 1 week, 4 weeks, 12 weeks, and 24 weeks postoperatively. Primary endpoint at 24 weeks.
Levator Function
Levator function measured in mm as excursion of upper eyelid margin from extreme downgaze to extreme upgaze with frontalis muscle blocked by examiner's thumb. Assessed by blinded outcomes assessor
Time frame: Baseline and 24 weeks postoperatively
Surgical Success Rate
Success defined as postoperative MRD1 between 3.5 to 4.5 mm with satisfactory lid contour and symmetry within 1 mm of contralateral normal eyelid at 24 weeks. Undercorrection defined as MRD1 less than 3.5 mm. Overcorrection defined as MRD1 greater than 5.5 mm.
Time frame: 24 weeks postoperatively
Postoperative Complications
Assessment of complications including overcorrection, undercorrection, lid contour abnormalities, eyelid asymmetry, suture granuloma, infection, hematoma, and need for reoperation.
Time frame: From surgery up to 24 weeks postoperatively
Plan to share: Yes — De-identified individual participant data will be available upon reasonable request to corresponding author 6 months after publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Preoperative baseline, and at 1 week, 4 weeks, 12 weeks, and 24 weeks postoperatively. Primary time point at 24 weeks.
Access criteria: Access Criteria: Access to de-identified individual participant data will be granted to researchers who provide a methodologically sound proposal approved by Zagazig University Research Ethics Committee. Request must include research question, analysis plan, and data protection plan. Data will be available 6 months after publication for 2 years. Requests should be directed to corresponding author via email. Type of data: De-identified individual participant data for MRD1, levator function, complications. Mechanism: Email to corresponding author.
Data sharing details ↗ · www.zu.edu.eg
Ran from Dec 2024 to primary completion in Jun 2025, 6 months.
Of 24 interventional studies with no phase under Blepharoptosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's 6 months is below that.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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