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

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

Recruiting
21-99 years
All
Phase N/A

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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.

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.

Eligibility

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

Study details
    Dry Eye

NCT07323264

Louis Tong

1 February 2026

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