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

December 28, 2025 updated by: Louis Tong

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patient undergoing cataract surgery that met the study inclusion and exclusion

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Post LVC with Dry Eye undergoing cataract surgery
High corneal Astigmatism with Dry Eye undergoing cataract surgery
Dry eye with no other risk factor undergoing cataract surgery
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
Patient undergoing Cataract Surgery implanted with Toric IOL With Dry Eye
Patient undergoing Cataract Surgery implanted with Monofocal IOL With Dry Eye
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
Patient undergoing Cataract Surgery implanted with Toric IOL Without Dry Eye
Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary outcome
Time Frame: From pre-op to Post Operative 3 to 6 weeks
Postoperative uncorrected visual acuity and repeatability of Biometry and Keratometry
From pre-op to Post Operative 3 to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Louis Tong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Carl Zeiss Meditec AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Louis Tong, PhD, Singapore Eye Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-0126 (Registry Identifier: SingHealth CIRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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