Clinical trial NCT04342988: Effect of Cequa Treatment on Accuracy of Pre-operative Biometry & Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
Official title: Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Research Insight LLC
Sponsor class: INDUSTRY
First posted: 2020-04-13
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with planned cataract surgery,
* The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale
* Reduced tear break up time (TBUT) ≤ 10 seconds.
* Able to comprehend and sign a statement of informed consent.
* Willing and able to complete all required postoperative visits.

Exclusion Criteria:

* Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
* Clinically significant ocular trauma.
* Active ocular Herpes simplex or Herpes Zoster infection
* Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
* Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
* Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
* Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
* Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
* Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
* Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
* Participation in this trial in the same patient's fellow eye
* Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.

Primary outcomes:
measure: Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.
timeFrame: Four weeks
Secondary outcomes:
measure: The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.
timeFrame: Four Weeks
measure: The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.
timeFrame: Four Weeks
measure: The difference in corneal staining before and after treatment with Cequa.
timeFrame: Four Weeks
measure: The difference in tear breakup time (TBUT) before and after treatment with Cequa.
timeFrame: Four Weeks
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Columbus
country: United States
facility: Ophthalmic Surgeons & Consultants of Ohio
state: Ohio
Study officials:
affiliation: Research Insight LLC
name: John Hovanesian, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.