Ocular surface diagnostics and care plans to improve cataract surgery results
SAS 1: Develop Ocular Disease (OSD) Diagnostic, Algorithms, and Management Protocols for Cataract Surgery
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 type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | Singapore National Eye Centre Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07323264 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Singapore
- Singapore Eye Research Institute — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Louis Tong, PhD — Singapore Eye Research Institute
- Study coordinator: Louis Tong, PhD
- Email: louis.tong.h.t@singhealth.com.sg
- Phone: 65767200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.