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

NCT06763731 | Recruiting Phase 4

• 1 other identifier: 202311109MIPD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ophthalmology

Keywords

Dry eye; Cataract surgery

Outcome Measures

Primary Outcomes (5)

• OSDI Dry Eye Questionnaire

  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.

  1-2 months

• Preoperative Assessments for Cataract Surgery at NTUH: Vision Measurement

  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.

  1-2 months

• Preoperative Assessments for Cataract Surgery at NTUH: Biometry

  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.

  1-2 months

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

  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.

  1-2 months

• K5 (Non-Invasive Tear Break-Up Time (NITBUT))

  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.

  1-2 months

Study Arms (1)

Experimental group

EXPERIMENTAL

Prospective, single-arm study

Drug: Systane COMPLETE

Interventions

Systane COMPLETE DRUG

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

Also known as: Experimental group

Experimental group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Alcon Research: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Chiun Ho Hou, Ph.D

CONTACT

+88623123456; chiunhohou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm study

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 8, 2025
• Study Start: May 2, 2024
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

TW (1)