Clinical trial NCT06763731: Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery
Official title: Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ophthalmology
Keywords: Dry eye
Cataract surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2025-01-08
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-arm study
Primary purpose: TREATMENT

Brief summary: Regular use of Systane COMPLETE in dry eye subjects before cataract surgery may optimize the ocular surface.

Detailed description: STUDY OBJECTIVE：To evaluate the impact of predicted residual astigmatism in mixed dry eye patients regularly using Systane COMPLETE before cataract surgery.

Hypothesis：Regular use of Systane COMPLETE in mixed dry eye subjects before cataract surgery may lead to more accurate astigmatism predictions.

Objectives：To evaluate the Impact of predicted residual astigmatism in mixed dry eye patients regularly using Systane COMPLETE before cataract surgery.

Inclusion Criteria The subjects aged 20-85 years, with normal cognitive function and capable of answering related questionnaires who require phacoemulsification and intraocular lens implantation under topical anaesthesia, are the eligible candidates.

Exclusion Criteria Unable to answer the questions in the dry eye survey. Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.

Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect.

Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.

Using dry eye medication at screening stage.

Research Process V1 Screening (1-2 month before surgery) The subjects' demographic information will be collected. The pre-op assessments will be performed, and Informed Consent will be explained and endorsed during this visit.

Systane COMPLETE MD1 bottle will be prescribed to all subjects who signed the ICF, with a dosing frequency of 1-2 drops q.i.d OU for 1-2 month.

The LENSTAR 900 device (Haag-Streit Swiss) will be used to measure the biometry of the anterior cornea's keratometry at each visit. The measurement will be taken through five consecutive scans with only a few seconds of interval between each scan. The mean keratometry of these five scans will be used.

Anterior corneal surface maps from Pentacam (OCULUS, Germany) will be used to identify patients with keratoconus or corneal irregularities at each visits.

V2 Pre-operative (7 days before surgery) All participants will receive refractive examinations and take dry eye assessments.

Repeat the same biometry measurement as the first visit. The final choice of the IOL for surgery is based on biometry measurements and Barrett Toric calculation.

One eye per subject will be analysed.

V3 Surgery day The participants will receive phacoemulsification and intraocular lens implantation. The participants with any intra-operative complication will be excluded from the study.

To ensure compliance with the medication, it is required that the subjects return the used Systane COMPLETE bottle and medication diary at V3.

Eligibility criteria: Inclusion Criteria:

The subjects aged 20-85 years, with normal cognitive function and capable of answering related questionnaires who require phacoemulsification and intraocular lens implantation under topical anaesthesia, are the eligible candidates.

Exclusion Criteria:

1. Unable to answer the questions in the dry eye survey.
2. Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
3. Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect
4. Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.
5. Using dry eye medication at screening stage

Primary outcomes:
measure: OSDI Dry Eye Questionnaire
timeFrame: 1-2 months
measure: Preoperative Assessments for Cataract Surgery at NTUH: Vision Measurement
timeFrame: 1-2 months
measure: Preoperative Assessments for Cataract Surgery at NTUH: Biometry
timeFrame: 1-2 months
measure: Preoperative Assessments for Cataract Surgery at NTUH: Pentacam(Corneal topography maps)
timeFrame: 1-2 months
measure: K5 (Non-Invasive Tear Break-Up Time (NITBUT))
timeFrame: 1-2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: