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

S

Sohag University

Status

Not yet enrolling

Conditions

Congenital Ptosis

Treatments

Procedure: levator muscle resection
Procedure: levator muscle plication

Study type

Interventional

Funder types

Other

Identifiers

NCT05895695
Soh-Med-23-03-01MS

Details and patient eligibility

About

The aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis.

Full description

Blepharotosis is one of the most encountered oculoplastic problems. Blepharoptosis is an abnormal low lying upper eyelid margin more than 2mm below the superior corneal limbus in the primary gaze position.

It can be subdivided according to the amount of levator function into poor (0-5),fair (6-11) or good (12 or more) millimeter. It can be classified also according to the degree of ptosis into mild (2mm) moderate (3mm) and severe ( 4mm or more). Surgical options for each of these groups are based on levator function as well as the degree and the cause of ptosis.

Enrollment

20 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • mild to moderate simple unilateral congenital ptosis with good to fair levator function

Exclusion criteria

  1. severe ptosis
  2. poor levator function
  3. poor Bell's phenomenon
  4. lagophthalmos
  5. diminished corneal sensation
  6. completed congenital or acquired ptosis
  7. history of previous lid surgery

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

1
Active Comparator group
Description:
evaluation of levator muscle resection on congenital ptosis
Treatment:
Procedure: levator muscle resection
2
Active Comparator group
Description:
evaluation of levator muscle plication on congenital ptosis
Treatment:
Procedure: levator muscle plication

Trial contacts and locations

1

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Central trial contact

Islam a Aboellil, lecturer; Maggi h Shaker, MBBCH

Data sourced from clinicaltrials.gov

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