SAS 1: Develop Ocular Disease (OSD) Diagnostic, Algorithms, and Management Protocols for Cataract Surgery
1 other identifier
observational
110
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2025
CompletedFirst Submitted
Initial submission to the registry
November 25, 2025
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
January 7, 2026
August 1, 2025
2 years
November 25, 2025
December 28, 2025
Conditions
Keywords
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
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
- Louis Tonglead
- Carl Zeiss Meditec AGcollaborator
Study Sites (1)
Singapore Eye Research Institute
Singapore, 169856, Singapore
Biospecimen
Tears Sample (Schirmers Test)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis Tong, PhD
Singapore Eye Research Institute
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