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

NCT ID: NCT07323264

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-27

Study Completion Date

2027-10-31

Brief Summary

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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

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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.

Conditions

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Dry Eye

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Post LVC with Dry Eye undergoing cataract surgery

Post LVC with Dry Eye undergoing cataract surgery

No interventions assigned to this group

High corneal Astigmatism with Dry Eye undergoing cataract surgery

High corneal Astigmatism with Dry Eye undergoing cataract surgery

No interventions assigned to this group

Dry eye with no other risk factor undergoing cataract surgery

Dry eye with no other risk factor undergoing cataract surgery

No interventions assigned to this group

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

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Patient undergoing Cataract Surgery implanted with Toric IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Toric IOL With Dry Eye

No interventions assigned to this group

Patient undergoing Cataract Surgery implanted with Monofocal IOL With Dry Eye

Patient undergoing Cataract Surgery implanted with Monofocal IOL With Dry Eye

No interventions assigned to this group

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

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Patient undergoing Cataract Surgery implanted with Toric IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Toric IOL Without Dry Eye

No interventions assigned to this group

Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye

Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role collaborator

Louis Tong

OTHER_GOV

Sponsor Role lead

Responsible Party

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Louis Tong

Clinician-Scientist, Senior Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Louis Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

Singapore Eye Research Institute

Locations

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Singapore Eye Research Institute

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Louis Tong, PhD

Role: CONTACT

Lee Jia Yi, MSc

Role: CONTACT

Facility Contacts

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Jiayi Lee, MSc65767200

Role: primary

Other Identifiers

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2025-0126

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-0126

Identifier Type: -

Identifier Source: org_study_id

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