Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02501187

Enrollment

Registered

2015-07-17

Start date

2015-10-08

Completion date

2020-07-31

Last updated

2018-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharoptosis

Brief summary

Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. Treatment is surgical and can be performed by three common procedures - Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement. A number of reports inspected the possibility that Blepharoptosis repair procedures may cause deterioration in dry eye status. The investigators would like to assess whether there is a difference between the different procedures in their influence on dry eye status.

Interventions

PROCEDURELevator advancement

A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

PROCEDUREMüller's muscle-conjunctival resection procedure

A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.

PROCEDUREWhite line advancement

A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Ptosis which indicate surgical repair * The ptosis must be suitable for repair in any of the procedures

Exclusion criteria

* Systemic disease which may cause ocular surface disease (eg Sjogren disease) * Previous orbital or eyelid surgery * Significantly dry eyes

Design outcomes

Primary

Measure	Time frame	Description
Diagnosis of objective or subjective deterioration in dry eye status	6 months	Dry eye status will be measured by a composite of tests, including Ocular surface disease index (OSDI) questionnaire (which indicates subjective status), and a number of objective tests - Shirmer test, Flurocein dye, Lissamine green dye and tear breakup time

Secondary

Measure	Time frame	Description
Ptosis repair procedure success	6 months	Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery

Countries

Israel

Contacts

Primary ContactMaya Eiger, MD

mayae2@clalit.org.il+972-3-9376107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026