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

Louis Tong

Status: Enrolling

Conditions: Dry Eye

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07323264

2025-0126 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

110 participants in 11 patient groups

Post LVC with Dry Eye undergoing cataract surgery

Description:

Post LVC with Dry Eye undergoing cataract surgery

High corneal Astigmatism with Dry Eye undergoing cataract surgery

Description:

High corneal Astigmatism with Dry Eye undergoing cataract surgery

Dry eye with no other risk factor undergoing cataract surgery

Description:

Dry eye with no other risk factor undergoing cataract surgery

Patient undergoing Cataract Surgery implanted with EDoF/ EDoF Toric IOL With Dry Eye

Description:

Patient undergoing Cataract Surgery implanted with EDoF/ EDoF Toric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric IOL With Dry Eye

Description:

Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Toric IOL With Dry Eye

Description:

Patient undergoing Cataract Surgery implanted with Toric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Monofocal IOL With Dry Eye

Description:

Patient undergoing Cataract Surgery implanted with Monofocal IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with EDoF/ EDoF Toric IOL Without Dry Eye

Description:

Patient undergoing Cataract Surgery implanted with EDoF/ EDoF Toric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric IOL Without Dry Eye

Description:

Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Toric IOL Without Dry Eye

Description:

Patient undergoing Cataract Surgery implanted with Toric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye

Description:

Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye