The main objective of this study is to demonstrate whether the number of patients with symptoms of dry eyes is significantly higher in patients with ptosis.
ID
Source
Brief title
Condition
- Ocular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Significant difference in proportion of patients with dry eyes between groups
(*2, α=0.05).
Secondary outcome
Schirmer-2 score, tear break-up time, corneal staining, degree of ptosis,
record of possible risk factors (previous trauma, contact lens wear, ocular
surgery, subjective complaints, punctate keratitis, blepharitis, etc.).
Background summary
Blepharoptosis (drooping eyelid) can cause loss of visual function. Because
surgical correction of the upper eyelid has been shown to significantly improve
the visual field, ptosis surgery has become a widely accepted and frequently
performed intervention. It is conjectured that prolonged incremental friction
between (dry) eye surface and upper eyelid may lead to some degree of
mechanical dysintegration of the aponeurosis. Therefore, a dry eye may form an
additional risk factor for aponeurotic ptosis. The objective of this study is
to determine whether a correlation can be demonstrated between dry eye and
ptosis.
Study objective
The main objective of this study is to demonstrate whether the number of
patients with symptoms of dry eyes is significantly higher in patients with
ptosis.
Study design
Open-label, prospective, single-center. Controls will be matched pairwise with
respect to gender and age to ptosis patients.
Study burden and risks
For patients presenting with complaints of ptosis, this study requires no extra
visits and no extra time. All investigational procedures are part of standard
medical examination. For controls, measurements will be performed during a
single visit which will take approximately 15 minutes.
Schiedamse Vest 180
3011 BH Rotterdam
Nederland
Schiedamse Vest 180
3011 BH Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Group 1 (ptosis):
- Diagnosis of gradually developed unilateral or bilateral ptosis of the upper eye lid.
- Age >= 40 years for patients not wearing contact lens(es) in affected eye(s).
- Age >= 20 years for patients wearing contact lens(es) in affected eye(s).
- Vertical eyelid fissure <= 7 mm in primary position.
- Bilateral levator function > 10 mm.;Group 2 (no ptosis):
- Age >= 40 years for patients not wearing contact lens(es).
- Age >= 20 years for patients wearing contact lens(es).
- Vertical eyelid fissure > 7 mm in primary position.
- Bilateral levator function > 10 mm.
- Age and gender match to a patient from group 1 ( |*age| < 5 years ).
Exclusion criteria
Group 1 (ptosis):
- Neurological disorder.
- Muscular disorder.
- Suspicion of other possible cause.;Group 2 (no ptosis):
- Neurological disorder.
- Muscular disorder.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14866.078.06 |