Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication

NCT05895695

Congenital Ptosis

UNKNOWN NA

Comparative Study Between Frontalis Flap Advancement Versus Frontalis Sling Operations in Mangment of Congenital Blepharoptosis

NCT05358002

Unrecognized Condition

COMPLETED NA

Surgical Management of Blepharoptosis

NCT03149367

Blepharoptosis

UNKNOWN NA

Comparison of Different Surgical Treatments for Severe Ptosis Correction

NCT03916107

Ptosis, Eyelid

UNKNOWN NA

Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles

NCT05643456

Exotropia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Target population for the study is children under twelve years old presenting to ophthalmology clinic at Cairo university specialized pediatric hospital with congenital ptosis.

Patients will be randomly divided into two groups First group (A) will contain 20 patients who will undergo standard levator aponeurosis resection Second group (B) will contain 20 patient who will undergo two point fixation levator tucking

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Ptosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

levator resection

20 patients who will undergo levator aponeurosis resection technique

Group Type ACTIVE_COMPARATOR

levator resection

Intervention Type PROCEDURE

The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.

The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect.

The skin incision closed by continuous suture with 6-0 prolene.

levator tucking

20 patients who will undergo two point fixation levator tucking technique

Group Type ACTIVE_COMPARATOR

levator tucking

Intervention Type PROCEDURE

The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.

. The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

levator resection

The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.

The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect.

The skin incision closed by continuous suture with 6-0 prolene.

Intervention Type PROCEDURE

levator tucking

The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.

. The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Unilateral or bilateral simple isolated congenital ptosis.
2. Levator function more than 4mm

Exclusion Criteria

1. Congenital ptosis associated with other ocular syndromes.
2. Recurrent ptosis following any attempt for repair.
3. Traumatic ptosis or acquired ptosis
4. -ve bell's phenomenon.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes