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The purpose of this study is to examine the effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.
Hypothesis: In patients with dry eye, defined as corneal staining and a reduced tear breakup time, the accuracy of pre-operative biometry and corneal surface HOAs will improve significantly after four weeks of Cequa treatment.
Primary Outcome Measure: Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.
Secondary Outcome Measures:
The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.
The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.
The difference in corneal staining and tear breakup time (TBUT) before and after treatment with Cequa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cequa Treatment In Cataract Patients with Dry Eye Disease | Other | Duration of Study Treatment - 4 weeks All patients will receive cyclosporine ophthalmic solution (0.09%) BID in both eyes for 28 days, 1 drop per dose. Dosing will be BID, both eyes, assuming both eyes will eventually undergo cataract surgery. Otherwise, single eye treatment in the operative eye will be permitted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cequa | Drug | The effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery. | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea. | Four Weeks | |
| The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment. | To compare the difference in Standard Patient of Eye Dryness Questionnaire (SPEED) scores before and after 4 weeks of therapy with Cequa BID among patients with significant dry eye (decreased TBUT or corneal staining) with planned cataract surgery. The SPEED questionnaire gives a score from 0-28 that is the result of 8 items that assess frequency and severity of symptoms. Speed Score Severity rating: 0-4 Mild, 5-7 Moderate, 8+ Severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hovanesian, MD | Research Insight LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States | ||
| Ophthalmology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17102664 | Background | Behrens A, Doyle JJ, Stern L, Chuck RS, McDonnell PJ, Azar DT, Dua HS, Hom M, Karpecki PM, Laibson PR, Lemp MA, Meisler DM, Del Castillo JM, O'Brien TP, Pflugfelder SC, Rolando M, Schein OD, Seitz B, Tseng SC, van Setten G, Wilson SE, Yiu SC; Dysfunctional tear syndrome study group. Dysfunctional tear syndrome: a Delphi approach to treatment recommendations. Cornea. 2006 Sep;25(8):900-7. doi: 10.1097/01.ico.0000214802.40313.fa. | |
| 21450919 |
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The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with, the Sponsor, and such that confidential or proprietary information is not disclosed
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| Four Weeks |
| The difference in corneal staining before and after treatment with Cequa. | The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale. | Four Weeks |
| The difference in tear breakup time (TBUT) before and after treatment with Cequa. | Reduced tear break up time (TBUT) ≤ 10 seconds. | Four Weeks |
| St Louis |
| Missouri |
| 63131 |
| United States |
| Ophthalmic Surgeons & Consultants of Ohio | Columbus | Ohio | 43215 | United States |
| Background |
| Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available. |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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