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Recruiting

NCT Number: NCT07323264

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

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.

Recruiting

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore Eye Research Institute

Singapore, 169856

Location status: Recruiting

Location contact

Jiayi Lee, MSc65767200

CONTACT

[email protected]

65767200

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Primary outcome

    Time frame: From pre-op to Post Operative 3 to 6 weeks

    Postoperative uncorrected visual acuity and repeatability of Biometry and Keratometry

Study contacts

Contact information is provided by the study sponsor or research team.

Lee Jia Yi, MSc

CONTACT

[email protected]

65767200

Louis Tong, PhD

CONTACT

[email protected]

65767200

Sponsors and collaborators

Lead sponsor

Louis Tong

Other Gov

Collaborators

  • Carl Zeiss Meditec AG

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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