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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07323264

Enrollment

110

Registered

2026-01-07

Start date

2025-06-27

Completion date

2027-10-31

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Cataract, EDOF, Monofocal IOL, Toric IOL, Post Lasik, High Corneal Astigmatism

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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Primary outcome	From pre-op to Post Operative 3 to 6 weeks	Postoperative uncorrected visual acuity and repeatability of Biometry and Keratometry

Countries

Singapore

Contacts

Primary ContactLouis Tong, PhD

louis.tong.h.t@singhealth.com.sg65767200

Backup ContactLee Jia Yi, MSc

lee.jiayi1@singhealth.com.sg65767200

Outcome results