Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery

Phase 4

Recruiting

• Conditions: Ophthalmology
• Interventions: Drug: Systane COMPLETE

• Registration Number: NCT06763731
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-05-02
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-01-15
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Systane COMPLETE	Prospective, single-arm study

Primary Outcome Measures

Name	Time	Method
OSDI Dry Eye Questionnaire	1-2 months	The Ocular Surface Disease Index (OSDI) questionnaire is a tool designed to evaluate dry eye symptoms, focusing on three aspects: self-reported eye discomfort, visual function impairment, and environmental triggers. The questionnaire contains 12 items, each rated on a scale from 0 to 4, with a total score ranging from 0 to 100. Higher scores indicate more severe dry eye symptoms. The OSDI questionnaire has high reliability and validity, aiding healthcare professionals in quickly assessing the severity of dry eye, making it suitable for clinical diagnosis and treatment evaluation.
Preoperative Assessments for Cataract Surgery at NTUH: Vision Measurement	1-2 months	Vision measurement is a core component of the preoperative baseline assessment, providing information on the patient's uncorrected and corrected visual acuity. This data helps determine the necessity of surgery and establish postoperative vision expectations.
Preoperative Assessments for Cataract Surgery at NTUH: Biometry	1-2 months	Biometry is an essential part of the preoperative evaluation, providing critical measurements that guide the selection of the appropriate intraocular lens. This assessment ensures precise surgical planning and contributes to achieving optimal visual outcomes postoperatively.
Preoperative Assessments for Cataract Surgery at NTUH: Pentacam(Corneal topography maps)	1-2 months	Pentacam is a vital component of the preoperative assessment, offering detailed corneal mapping that aids in evaluating corneal structure and detecting any abnormalities. This information supports surgical planning and enhances the accuracy of intraocular lens selection, contributing to improved postoperative visual outcomes.
K5 (Non-Invasive Tear Break-Up Time (NITBUT))	1-2 months	K5 (Non-Invasive Tear Break-Up Time (NITBUT)) is used to evaluate tear film stability, a key diagnostic indicator for dry eye. It is crucial for enhancing postoperative visual quality.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan