NCT03373812

Brief Summary

Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance. In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis:

  1. 1.anterior approach - skin incision and levator muscle insertion advancement.
  2. 2.posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

December 4, 2017

Last Update Submit

December 13, 2017

Conditions

Involutional Ptosis

Outcome Measures

Primary Outcomes (3)

  • MRD1

    Distance in millimeters between corneal light reflex and upper eyelid margin

    6 months

  • surgery duration

    Time from first incision to last suture (in minutes)

    3 hours

  • Levator function

    change (in millimeters) in upper eyelid position from downgaze to maximal upgaze

    6 months

Secondary Outcomes (2)

  • Need for additional eyelid surgery

    6 months

  • Eyelid or ocular secondary disease

    6 months

Study Arms (2)

anterior approach

ACTIVE COMPARATOR

patients having involutional ptosis undergoing anterior approach surgical ptosis repair (Levator advancement)

Procedure: Blepharoptosis repair

posterior approach

ACTIVE COMPARATOR

patients having involutional ptosis undergoing posterior approach surgical ptosis repair (mullerectomy)

Procedure: Blepharoptosis repair

Interventions

Blepharoptosis repairPROCEDURE

levator advancement or mullerectomy

anterior approachposterior approach

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Involutional ptosis
  • No previous eyelid surgery

You may not qualify if:

  • Previous eyelid surgery or trauma
  • Congenital ptosis
  • Previous glaucoma filtrartion surgery
  • Unwillingness for six months followup

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Patel RM, Aakalu VK, Setabutr P, Putterman AM. Efficacy of Muller's Muscle and Conjunctiva Resection With or Without Tarsectomy for the Treatment of Severe Involutional Blepharoptosis. Ophthalmic Plast Reconstr Surg. 2017 Jul/Aug;33(4):273-278. doi: 10.1097/IOP.0000000000000748.

    PMID: 27429227BACKGROUND

  • Chang S, Lehrman C, Itani K, Rohrich RJ. A systematic review of comparison of upper eyelid involutional ptosis repair techniques: efficacy and complication rates. Plast Reconstr Surg. 2012 Jan;129(1):149-157. doi: 10.1097/PRS.0b013e318230a1c7.

    PMID: 22186506BACKGROUND

  • Sohrab MA, Lissner GS. Comparison of Fasanella-Servat and Small-Incision Techniques for Involutional Ptosis Repair. Ophthalmic Plast Reconstr Surg. 2016 Mar-Apr;32(2):98-101. doi: 10.1097/IOP.0000000000000417.

    PMID: 25719375BACKGROUND

  • Ben Simon GJ, Joseph J, Lee S, Schwarcz RM, McCann JD, Goldberg RA. External versus endoscopic dacryocystorhinostomy for acquired nasolacrimal duct obstruction in a tertiary referral center. Ophthalmology. 2005 Aug;112(8):1463-8. doi: 10.1016/j.ophtha.2005.03.015.

    PMID: 15953636BACKGROUND

  • Liu D. Ptosis repair by single suture aponeurotic tuck. Surgical technique and long-term results. Ophthalmology. 1993 Feb;100(2):251-9. doi: 10.1016/s0161-6420(93)31662-3.

    PMID: 8437835BACKGROUND

Study Officials

  • Arie Nemet, Prof. (MD)

    ophthalmology depertmant, MeirMc, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arie Nemet, Prof. (MD)

CONTACT

+972-9-7471527nemet.arik@gmail.com

Tal Sharon, Dr.(MD)

CONTACT

+972-7472154tal.sharon.p@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 14, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

December 14, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share