Dry Eye
Conditions
Brief 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.
Interventions
PROCEDURECataract Surgery and Limbal relaxing incision
Cataract extraction and limbal-relaxing incisions
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3 | Baseline, 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. |
| Change From Baseline in Corneal Staining at Month 3 | Baseline, 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). |
| Change From Baseline in Conjunctival Staining at Month 3 | Baseline, 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) |
| Change From Baseline in Tear Break-Up Time at Month 3 | Baseline, 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). |
| Change From Baseline in Schirmer's Test at Month 3 | Baseline, 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Cataract and Corneal Astigmatism Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Patients With Cataract and Corneal Astigmatism |
|---|---|
| Age Continuous | 68.29 years |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Month 3
Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Cataract and Corneal Astigmatism | The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured | Area 1 (Center) at Month 3 | 13 Percentage of Subjects |
| Patients With Cataract and Corneal Astigmatism | The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured | Area 2 (Center of LRI 1) at Month 3 | 13 Percentage of Subjects |
| Patients With Cataract and Corneal Astigmatism | The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured | Area 3 (Center of LRI 2) at Month 3 | 21.7 Percentage of Subjects |
| Patients With Cataract and Corneal Astigmatism | The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured | Area 4 (90 degrees from LRI 1) at Month 3 | 13 Percentage of Subjects |
| Patients With Cataract and Corneal Astigmatism | The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured | Area 5 (90 degrees from LRI 2) at Month 3 | 8.7 Percentage of Subjects |
Secondary
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)
Time frame: Baseline, Month 3
Population: Subjects enrolled who met the inclusion criteria of having 2 limbal incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Conjunctival Staining at Month 3 | Baseline | 1.087 Scores on a Scale | Standard Deviation 2.557 |
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Conjunctival Staining at Month 3 | Change from Baseline at Month 3 | -0.174 Scores on a Scale | Standard Deviation 2.949 |
Secondary
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).
Time frame: Baseline, Month 3
Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Corneal Staining at Month 3 | Change from Baseline at Month 3 | 0.261 Scores on a Scale | Standard Deviation 2.158 |
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Corneal Staining at Month 3 | Baseline | 0.652 Scores on a Scale | Standard Deviation 1.668 |
Secondary
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.
Time frame: Baseline, Month 3
Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3 | Change from Baseline at Month 3 | -9.826 Scores on a Scale | Standard Deviation 7.912 |
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3 | Baseline | 15.739 Scores on a Scale | Standard Deviation 8.368 |
Secondary
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).
Time frame: Baseline, Month 3
Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Schirmer's Test at Month 3 | Baseline | 11.091 Millimeters of Tears | Standard Deviation 5.163 |
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Schirmer's Test at Month 3 | Change from Baseline at Month 3 | 0.909 Millimeters of Tears | Standard Deviation 5.74 |
Secondary
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).
Time frame: Baseline, Month 3
Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Tear Break-Up Time at Month 3 | Baseline | 16.4 Seconds | Standard Deviation 12.5 |
| Patients With Cataract and Corneal Astigmatism | Change From Baseline in Tear Break-Up Time at Month 3 | Change from Baseline at Month 3 | -3.71 Seconds | — |