Optimizing the Ocular Surface With Systane COMPLETE Pre- and Post-operatively in Patients With Dry Eye Planning for Cataract Surgery: An Extension Study of Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery

NCT06886373 | Recruiting Phase 4

• 1 other identifier: 202408096MIND
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism, as well as the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).

Conditions

Ophthalmology

Keywords

Dry eye; cataract surgery; astigmatism; nano-emulsion; artificial tears

Outcome Measures

Primary Outcomes (1)

• The change of the keratometry data before and after using Systane COMPLETE

  The change of the keratometry data is assessed for investigating ocular surface stability after using Systane COMPLETE. The keratometry data is measured using auto-refractor.

  1-2 months

Secondary Outcomes (5)

• The change of the refractive power before and after using Systane COMPLETE

  1-2 months

• The change of the biometry parameter before and after using Systane COMPLETE

  1-2 months

• The change of corneal topology map before and after using Systane COMPLETE

  1-2 months

• The change of Ocular Surface Disease Index (OSDI) before and after using Systane COMPLETE

  1-2 months

• The change of Non-Invasive Tear Break-Up Time (NITBUT) before and after using Systane COMPLETE

  1-2 months

Study Arms (2)

Systane COMPLETE

EXPERIMENTAL

The experimental group will receive Systane COMPLETE for one month before undergoing the cataract surgery and receive for one month since one week after the surgery.

Drug: Systane Complete

Control group

NO INTERVENTION

The control group will enrolled people who meet the same age and same dry eye syndrome criteria as the experimental group. The control group will not received any intervention.

Interventions

Systane Complete DRUG

Systane COMPLETE is an artificial tears that contain nano-emulsion of mineral oil and phospholipids.

Systane COMPLETE

Eligibility Criteria

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

You may not qualify if:

• Cataract patients aged between 20 and 85 years.
• Patients with normal cognitive function who are able to complete the dry eye questionnaire (with - responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens implantation under topical anesthesia.
• 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

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Astigmatism

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Refractive Errors

Study Officials

• Chiun Ho Hou, Ph.D

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiun Ho Hou, Ph.D

CONTACT

+88623123456; chiunhohou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, double-arm study

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 20, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)