SAS 1: Develop Ocular Disease (OSD) Diagnostic, Algorithms, and Management Protocols for Cataract Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dry Eye. Basic parameters: 21 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Phase 1: Investigate the impact of ocular surface disease (OSD) on post-operative outcomes in cataract surgery.
Phase 1A: Longitudinal interventional parallel group study; small cohort to determine the impact of moderate dry eye for at-risk patient groups.
Phase 1B: Longitudinal interventional parallel group study; larger cohort of to compare outcomes based on different IOL types.
Primary outcome measures
- Primary outcome [Time frame: From pre-op to Post Operative 3 to 6 weeks]
Eligibility criteria
Inclusion criteria
- Inclusion criteria for dry eye (participant must meet at least 1 of the inclusion criteria below):
- 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
Inclusion criteria to fulfil all for controls (patients w/o dry 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.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Singapore · 1 center
- Singapore Eye Research Institute — Singapore
Identifiers
NCT: NCT07323264 · 2025-0126 · 2025-0126