Dry EyeNCT01161771

Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye

An observational study of Dry Eye, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Dry Eye
What is being tested?: Cataract Surgery and Limbal relaxing incision
Type of treatment: Surgery or procedure
How many people: 32 participants
Where: 1 siteUnited States
Study dates: May 2010to Dec 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing cataract extraction and limbal relaxing incision

Who may be able to join

Patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism

Who cannot join

Uncontrolled systemic disease
Have undergone refractive surgery or any surgery involving a limbal or corneal incision
Use of topical cyclosporine (Restasis) within three months of baseline/randomization visit
Temporary or permanent occlusion of the lacrimal puncta

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Long Island City, New York

Other trials in United States

About this study

This is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.

Conditions: Dry Eye
Being tested: Cataract Surgery and Limbal relaxing incision
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cataract Surgery and Limbal relaxing incisionProcedure or surgery
Cataract extraction and limbal-relaxing incisions

Study groups in NCT01161771
Study group	Role	What they receive
Patients with cataract and corneal astigmatism		Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) Receives: Procedure: Cataract Surgery and Limbal relaxing incision

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
The percentage of subjects at month 3 with corneal sensitivity < 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.
Measured: Month 3

Secondary outcomes (5)

Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3
Change from baseline in OSDI total score at month 3. The OSDI is a 12-question survey for subjects to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Measured: Baseline, Month 3
Change From Baseline in Corneal Staining at Month 3
Change from baseline in corneal staining at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A positive number change from baseline represents an increase in corneal staining (worsening of dry eye).
Measured: Baseline, Month 3
Change From Baseline in Conjunctival Staining at Month 3
Change from baseline in conjunctival staining severity score at month 3. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0= no staining, 5= severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement)
Measured: Baseline, Month 3
Change From Baseline in Tear Break-Up Time at Month 3
Change from baseline in tear break-up time (TBUT) at month 3. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A negative number change from baseline indicates a decrease in TBUT (worsening).
Measured: Baseline, Month 3
Change From Baseline in Schirmer's Test at Month 3
Change from baseline in Schirmer's Test result at month 3. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement).
Measured: Baseline, Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Dec 2010

First posted14 Jul 2010 (estimated)
Study startMay 2010
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01161771
Sponsor's protocol ID: MA-RES-09-004
Status last verified: Jul 2012
First submitted: 6 Jul 2010
Last updated: 26 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye
ClinicalTrials.gov ID: NCT01161771
Acronym / sponsor ID: MA-RES-09-004
Conditions: Dry Eye
Study type: Observational
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 14 Jul 2010 (estimated)
Results: Posted 26 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with cataract and corneal astigmatism	–	Procedure: Cataract Surgery and Limbal relaxing incisionPatients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing cataract extraction and limbal relaxing incision

Key inclusion criteria (1 listed)

Patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism

Key exclusion criteria (4 listed)

Uncontrolled systemic disease
Have undergone refractive surgery or any surgery involving a limbal or corneal incision
Use of topical cyclosporine (Restasis) within three months of baseline/randomization visit
Temporary or permanent occlusion of the lacrimal puncta

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cataract Surgery and Limbal relaxing incisionCataract extraction and limbal-relaxing incisions	Procedure or surgery	Patients with cataract and corneal astigmatism

Primary outcome

The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
Time frame: Month 3
The percentage of subjects at month 3 with corneal sensitivity < 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.

5 secondary outcomes

Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3
Time frame: Baseline, Month 3
Change From Baseline in Corneal Staining at Month 3
Time frame: Baseline, Month 3
Change From Baseline in Conjunctival Staining at Month 3
Time frame: Baseline, Month 3
Change From Baseline in Tear Break-Up Time at Month 3
Time frame: Baseline, Month 3
Change From Baseline in Schirmer's Test at Month 3
Time frame: Baseline, Month 3

Results and safety

Results posted to the registry on 26 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Cataract and Corneal Astigmatism	32	32

Primary outcome: The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured

Time frame: Month 3. Number. Unit: Percentage of Subjects

Measure	Patients With Cataract and Corneal Astigmatism n = 23
Area 1 (Center) at Month 3	13
Area 2 (Center of LRI 1) at Month 3	13
Area 3 (Center of LRI 2) at Month 3	21.7
Area 4 (90 degrees from LRI 1) at Month 3	13
Area 5 (90 degrees from LRI 2) at Month 3	8.7

Population analysed: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Cataract and Corneal Astigmatism	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eye, run by Allergan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured (time frame: Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01161771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.