Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with cataract and corneal astigmatism Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) |
Procedure: Cataract Surgery and Limbal relaxing incision
Cataract extraction and limbal-relaxing incisions
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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).
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Long Island | New York | United States |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA-RES-09-004
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Patients With Cataract and Corneal Astigmatism |
|---|---|
| Arm/Group Description | Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) |
| Period Title: Overall Study | |
| STARTED | 32 |
| COMPLETED | 32 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Patients With Cataract and Corneal Astigmatism |
|---|---|
| Arm/Group Description | Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) |
| Overall Participants | 32 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
68.29
|
| Sex: Female, Male (Count of Participants) | |
| Female |
21
65.6%
|
| Male |
11
34.4%
|
Outcome Measures
| Title | The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Patients With Cataract and Corneal Astigmatism |
|---|---|
| Arm/Group Description | Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) |
| Measure Participants | 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
|
| Title | Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Patients With Cataract and Corneal Astigmatism |
|---|---|
| Arm/Group Description | Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) |
| Measure Participants | 23 |
| Baseline |
15.739
(8.368)
|
| Change from Baseline at Month 3 |
-9.826
(7.912)
|
| Title | Change From Baseline in Corneal Staining at Month 3 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Patients With Cataract and Corneal Astigmatism |
|---|---|
| Arm/Group Description | Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) |
| Measure Participants | 23 |
| Baseline |
0.652
(1.668)
|
| Change from Baseline at Month 3 |
0.261
(2.158)
|
| Title | Change From Baseline in Conjunctival Staining at Month 3 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects enrolled who met the inclusion criteria of having 2 limbal incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI. |
| Arm/Group Title | Patients With Cataract and Corneal Astigmatism |
|---|---|
| Arm/Group Description | Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) |
| Measure Participants | 23 |
| Baseline |
1.087
(2.557)
|
| Change from Baseline at Month 3 |
-0.174
(2.949)
|
| Title | Change From Baseline in Tear Break-Up Time at Month 3 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Patients With Cataract and Corneal Astigmatism |
|---|---|
| Arm/Group Description | Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) |
| Measure Participants | 23 |
| Baseline |
16.4
(12.5)
|
| Change from Baseline at Month 3 |
-3.71
(NA)
|
| Title | Change From Baseline in Schirmer's Test at Month 3 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Patients With Cataract and Corneal Astigmatism |
|---|---|
| Arm/Group Description | Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) |
| Measure Participants | 23 |
| Baseline |
11.091
(5.163)
|
| Change from Baseline at Month 3 |
0.909
(5.74)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | Serious Adverse Events and Adverse Events were not collected. | |
| Arm/Group Title | Patients With Cataract and Corneal Astigmatism | |
| Arm/Group Description | Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions) | |
All Cause Mortality |
||
| Patients With Cataract and Corneal Astigmatism | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Patients With Cataract and Corneal Astigmatism | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Patients With Cataract and Corneal Astigmatism | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
| Name/Title | Vice President, Global Medical Affairs |
|---|---|
| Organization | Allergan, Inc. |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
- MA-RES-09-004