Clinical trial Recruiting at 1 site Observational Ages 21 to 99

Ocular surface diagnostics and care plans to improve cataract surgery results

Official title: SAS 1: Develop Ocular Disease (OSD) Diagnostic, Algorithms, and Management Protocols for Cataract Surgery

Run by Singapore National Eye Centre · NCT07323264 · Data updated 2026-11-12

This project will try using new tear and cornea imaging plus tailored preoperative care to help people with dry eye get better vision after cataract surgery.

Quick facts

Study typeObservational
Ages21 Years to 99 Years
SexAll
Enrollment110 (estimated)
SponsorSingapore National Eye Centre
Government
Locations1 site (Singapore)
StatusRecruiting
StartedJune 27, 2025
Main results expectedJune 30, 2027
Study endsOctober 31, 2027
Registry record updatedJanuary 7, 2026
Trial IDNCT07323264 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults planning cataract surgery who either have symptomatic dry eye (DEQ-5 >6 with short TBUT or corneal staining, or ongoing dry-eye topical therapy or punctal plugs) or patients without dry eye who meet the control criteria.

Probably not a fit

Patients with other eye conditions that affect vision as much as cataract (for example active corneal stromal disease or scar, significant corneal endothelial disease) or with active systemic autoimmune conditions like Sjögren's, untreated thyroid dysfunction, or rheumatoid arthritis are excluded and may not benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This program is a longitudinal, interventional effort with parallel groups designed to clarify how ocular surface disease affects cataract surgery outcomes and to test management algorithms. Phase 1A enrolls a small cohort to determine the impact of moderate dry eye in at-risk patient groups, and Phase 1B expands to a larger cohort to compare outcomes across different intraocular lens (IOL) types. The work uses advanced tear-film and corneal imaging alongside standardized dry eye criteria and treatment pathways, with follow-up of postoperative visual and satisfaction measures. Results will be used to propose practical preoperative diagnostic and management protocols for the ocular surface.

Why it matters

Potential benefit: If successful, this could reduce poor visual outcomes and patient dissatisfaction after cataract surgery by improving detection and management of tear-film problems before surgery.

How similar studies have gone: Smaller prior studies and clinical experience indicate that treating dry eye before cataract surgery can improve outcomes, but there is no universally accepted preoperative algorithm, so this work builds on promising but heterogeneous evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Inclusion criteria for dry eye (participant must meet at least 1 of the inclusion criteria below):

  1. Symptomatic for dry eye based on DEQ5 (\>6) and \[either TBUT less than 5 s or staining \>grade 1 in any zone of the cornea\]
  2. 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

Inclusion criteria to fulfil all for controls (patients w/o dry eye):

1. DEQ5 \<=6.
2. Staining \< grade 1 in at least one corneal zone.
3. Not using diquasfosol, cyclosporine, tacrolimus in last 2 months.
4. No visible punctal plugs.

Exclusion Criteria:

* 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

Where it's running

  • Singapore Eye Research Institute
    Singapore, Singapore
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.