Dry EyeNCT07323264
SAS 1: Develop Ocular Disease (OSD) Diagnostic, Algorithms, and Management Protocols for Cataract Surgery
An observational study of Dry Eye, run by Louis Tong at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- How many people
- 110 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Jun 2025to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient undergoing cataract surgery that met the study inclusion and exclusion
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore Eye Research Institute
Singapore, 169856
Jiayi Lee, MSc65767200, 65767200, lee.jiayi1@singhealth.com.sg
About this study
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.
Read the 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.
- Conditions
- Dry Eye
- Keywords
- Cataract, EDOF, Monofocal IOL, Toric IOL, Post Lasik, High Corneal Astigmatism
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post LVC with Dry Eye undergoing cataract surgery | Post LVC with Dry Eye undergoing cataract surgery | |
| High corneal Astigmatism 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 | 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 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 Multifocal/ MultifocalToric IOL With Dry Eye | |
| Patient undergoing Cataract Surgery implanted with Toric 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 Monofocal IOL With Dry Eye | |
| 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 | |
| Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric 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 Toric IOL Without Dry Eye | |
| Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye | Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Postoperative uncorrected visual acuity and repeatability of Biometry and Keratometry
Measured: From pre-op to Post Operative 3 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start27 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Tong
- Sponsor type
- Other government
- Collaborators
- Carl Zeiss Meditec AG
- Responsible party
- Sponsor-investigator, Louis Tong, Singapore National Eye Centre
- Investigators
- Louis Tong, PhD, Principal investigator, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323264
- Sponsor's protocol ID
- 2025-0126
- Other IDs
- 2025-0126
- Status last verified
- Aug 2025
- First submitted
- 25 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAS 1: Develop Ocular Disease (OSD) Diagnostic, Algorithms, and Management Protocols for Cataract Surgery
- ClinicalTrials.gov ID
- NCT07323264
- Acronym / sponsor ID
- 2025-0126
- Conditions
- Dry Eye
- Keywords
- Cataract, EDOF, Monofocal IOL, Toric IOL, Post Lasik, High Corneal Astigmatism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Louis TongOther government
- Collaborators
- Carl Zeiss Meditec AG
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Post LVC with Dry Eye undergoing cataract surgery | – | –Post LVC with Dry Eye undergoing cataract surgery |
| High corneal Astigmatism 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 | – | –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 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 Multifocal/ MultifocalToric IOL With Dry Eye |
| Patient undergoing Cataract Surgery implanted with Toric 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 Monofocal IOL With Dry Eye |
| 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 |
| Patient undergoing Cataract Surgery implanted with Multifocal/ MultifocalToric 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 Toric IOL Without Dry Eye |
| Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye | – | –Patient undergoing Cataract Surgery implanted with Monofocal IOL Without Dry Eye |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing cataract surgery that met the study inclusion and exclusion
Key inclusion criteria (8 listed)
- Inclusion criteria for dry eye (participant must meet at least 1 of the inclusion criteria below):
- DEQ5 <=6.
- Staining < grade 1 in at least one corneal zone.
- Not using diquasfosol, cyclosporine, tacrolimus in last 2 months.
- No visible punctal plugs.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcome
Time frame: From pre-op to Post Operative 3 to 6 weeks
Postoperative uncorrected visual acuity and repeatability of Biometry and Keratometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louis Tong, PhD principal investigator
Singapore Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Louis Tong at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis Tong, PhD (65767200, louis.tong.h.t@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: From pre-op to Post Operative 3 to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.