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NCT Number: NCT06763731

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

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

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Key information

Conditions

Ophthalmology Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Chiun Ho MD Hou

CONTACT

[email protected]

+88623123456 ext. 262131

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systane COMPLETE

Drug

Preop dry eye management using Systane COMPLETE can help to optimize the ocular surface.

Other names: Experimental group

Primary outcomes

  1. OSDI Dry Eye Questionnaire

    Time frame: 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.

  2. Preoperative Assessments for Cataract Surgery at NTUH: Vision Measurement

    Time frame: 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.

  3. Preoperative Assessments for Cataract Surgery at NTUH: Biometry

    Time frame: 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.

  4. Preoperative Assessments for Cataract Surgery at NTUH: Pentacam(Corneal topography maps)

    Time frame: 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.

  5. K5 (Non-Invasive Tear Break-Up Time (NITBUT))

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiun Ho Hou, Ph.D

CONTACT

[email protected]

+88623123456 ext. 262131

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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