NCT07323264

Brief Summary

Patient: Tear film issues resulting in poor visual outcomes are a major cause of dissatisfaction after cataract surgery. There is no universal best preoperative algorithm for managing the ocular surface prior to surgery. Industry: Recent advances in tear/cornea imaging and refractive cataract surgery such as multifocal intraocular lenses will be advantageous to patients only if tear film issues can be addressed. Society: Cataract surgery is the most common ophthalmic surgery done in Singapore and worldwide. Improving vision by attending to tear film problems improves quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jun 2025Oct 2027

Study Start

First participant enrolled

June 27, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

January 7, 2026

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

November 25, 2025

Last Update Submit

December 28, 2025

Conditions

Keywords

CataractEDOFMonofocal IOLToric IOLPost LasikHigh Corneal Astigmatism

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

    Postoperative uncorrected visual acuity and repeatability of Biometry and Keratometry

    From pre-op to Post Operative 3 to 6 weeks

Study Arms (11)

Post LVC with Dry Eye undergoing cataract surgery

Post LVC with Dry Eye undergoing cataract surgery

High corneal Astigmatism with Dry Eye undergoing cataract surgery

High corneal Astigmatism with Dry Eye undergoing cataract surgery

Dry eye with no other risk factor undergoing cataract surgery

Dry eye with no other risk factor undergoing cataract surgery

Patient undergoing Cataract Surgery implanted with EDoF/ EDoF Toric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with EDoF/ EDoF Toric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Toric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Toric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Monofocal IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Monofocal IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with EDoF/ EDoF Toric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with EDoF/ EDoF Toric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Toric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Toric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient undergoing cataract surgery that met the study inclusion and exclusion

You may qualify if:

  • Symptomatic for dry eye based on DEQ5 (\>6) and \[either TBUT less than 5 s or staining \>grade 1 in any zone of the cornea\]
  • Either use of diquasfosol, cyclosporine eyedrops or tacrolimus eyedrops for dry eye disease in the last 2 weeks (and previously started for more than 2 months), OR current and visible lower punctal plugs in at least one eye
  • DEQ5 \<=6.
  • Staining \< grade 1 in at least one corneal zone.
  • Not using diquasfosol, cyclosporine, tacrolimus in last 2 months.
  • No visible punctal plugs.

You may not qualify if:

  • If there is another ocular condition which affects vision as much as cataract: active corneal stromal disease or scar or significant corneal endothelial disease
  • Known diagnosis of active thyroid dysfunction, Sjogren disease and rheumatoid arthritis
  • Intraocular surgery within the previous 6 months
  • Laser-assisted in situ keratomileusis or pterygium surgery within the previous 3 months
  • Central nervous system and hormonal drugs required within the last month and during the study
  • Active ocular infection, inflamed chalazion, or presence of pterygium
  • Glaucoma which requires topical anti-glaucoma medications
  • Any need to wear contact lens during the study
  • Having issues which make it difficult to follow up (eg., wheelchair, etc)
  • Pregnant and breast-feeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Eye Research Institute

Singapore, 169856, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tears Sample (Schirmers Test)

MeSH Terms

Conditions

Dry Eye SyndromesCataract

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesLens Diseases

Study Officials

  • Louis Tong, PhD

    Singapore Eye Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinician-Scientist, Senior Consultant

Study Record Dates

First Submitted

November 25, 2025

First Posted

January 7, 2026

Study Start

June 27, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

January 7, 2026

Record last verified: 2025-08

Locations