Anterior Versus Posterior Surgery for Eyelid Ptosis

Participants assigned to this arm will undergo levator aponeurosis advancement and reattachment through an anterior (transcutaneous) approach, accessing the aponeurosis through the eyelid skin and orbicularis muscle. Surgery will be performed under local anesthesia by an experienced surgeon. This arm serves as the active comparator. Participants will receive routine postoperative care and follow-up for 6 months.

Surgical correction of aponeurotic ptosis by advancement and reattachment of the levator aponeurosis through an anterior transcutaneous approach. The aponeurosis is accessed through the upper eyelid skin and orbicularis muscle to restore upper eyelid height. The procedure is performed under local anesthesia by a surgeon experienced in both study techniques.

Participants assigned to this arm will undergo levator aponeurosis advancement and reattachment through a posterior (transconjunctival) approach, accessing the aponeurosis through the inner surface of the eyelid. Surgery will be performed under local anesthesia by the same experienced surgeon. This arm will be evaluated for noninferiority to the anterior approach. Participants will receive routine postoperative care and follow-up for 6 months.

Surgical correction of aponeurotic ptosis by advancement and reattachment of the levator aponeurosis through a posterior transconjunctival approach (white-line advancement). The aponeurosis is accessed through the inner surface of the upper eyelid to restore upper eyelid height. The procedure is performed under local anesthesia by the same surgeon performing the anterior approach.

Upper eyelid height assessed using margin reflex distance 1 (MRD1), defined as the vertical distance in millimeters between the upper eyelid margin and the corneal light reflex in primary gaze. Measurements will be performed by an independent healthcare professional. MRD1 at 6 months will be compared between the posterior and anterior levator aponeurosis advancement groups to assess noninferiority of the posterior approach.

Number of participants experiencing at least one postoperative complication during the 6-month follow-up period. Complications include infection, bleeding, corneal abnormalities, and wound or suture dehiscence. The type of complication will also be recorded. The proportion of participants with complications will be compared between the two surgical groups.

Duration of the surgical procedure, measured in minutes. For the anterior approach, surgical time is measured from the skin incision to the start of skin closure. For the posterior approach, surgical time is measured from the transconjunctival incision to placement of the final fixation suture. Surgical duration will be compared between groups.

Postoperative eyelid swelling assessed using the edema component of the Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE) scale, as specified in the study protocol. The four grades range from 1 (no coverage of the iris by swollen eyelids) to 4 (complete eye closure due to swelling). Higher scores indicate greater edema. Scores will be recorded separately for each assessed side and compared between surgical groups.

Postoperative bruising assessed using the ecchymosis component of the Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE) scale, as specified in the study protocol. Scores range from 0 (no ecchymosis) to 3 (ecchymosis extending over more than two-thirds of the eyelid length). Higher scores indicate more extensive bruising. Scores will be recorded separately for each assessed side and compared between surgical groups.

Postoperative eyelid appearance assessed by an independent healthcare professional using the study-specific cosmetic rating scale. Scores range from 0 to 10 and will be recorded at each scheduled cosmetic assessment. Cosmetic scores will be compared between the two surgical groups.

Overall patient satisfaction with ptosis surgery assessed using the five-point question in the study-specific patient questionnaire. Responses are scored as 1 (very dissatisfied), 2 (dissatisfied), 3 (neutral), 4 (satisfied), or 5 (very satisfied). Higher scores indicate greater satisfaction. Participants may also select reasons for satisfaction or dissatisfaction, including appearance, eyelid function, and postoperative symptoms. Overall satisfaction scores will be compared between surgical groups.

Change in upper eyelid height calculated as MRD1 at 6 months after surgery minus preoperative MRD1, measured in millimeters. MRD1 is the vertical distance between the upper eyelid margin and the corneal light reflex in primary gaze. A positive change indicates an increase in upper eyelid height relative to baseline. The change will be compared between the two surgical groups.

Repeated measurements of margin reflex distance 1 (MRD1), in millimeters, used to assess the evolution and stability of upper eyelid position after surgery. MRD1 is the vertical distance between the upper eyelid margin and the corneal light reflex in primary gaze. Measurements obtained at each follow-up visit will be performed by an independent healthcare professional and compared between the posterior and anterior levator aponeurosis advancement groups.

Vertical distance between the upper and lower eyelid margins, measured in millimeters in primary gaze. Measurements will be obtained before surgery and at the scheduled postoperative visits to characterize changes in eyelid opening. Palpebral fissure height will be compared between the two surgical groups.