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NCT Number: NCT07809022

Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery

Dry eye disease can occur or worsen after cataract surgery and may cause ocular discomfort and reduced visual quality. Standard treatment commonly includes artificial tear eye drops, which provide temporary lubrication. Temporary occlusion of the tear drainage system may offer an alternative approach by increasing tear retention and improving tear film stability.

This prospective, randomized, double-blind, inter-eye study will evaluate the use of LACRIFILL® Canalicular Gel, a crosslinked hyaluronic acid gel placed in the tear drainage system, in patients who have undergone bilateral cataract surgery. Treatment allocation will be randomized at the eye level within each participant. One eye will be assigned to treatment with LACRIFILL®, while the fellow eye will serve as the control and receive standard care with artificial tear eye drops.

The study will compare the development and severity of dry eye disease between the randomized treatment and control eyes. The main outcome will be tear production measured by the Schirmer Test 1 one month after treatment. Additional assessments will include tear film stability, ocular surface findings, anterior segment imaging, visual quality, dry eye symptoms, use of artificial tears, and treatment-related safety outcomes during a three-month follow-up period.

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Key information

Conditions

Dry Eye Dry Eye Disease (DED) Dry Eye Sensation After Cataract Surgery Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

45 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Department of Ophthalmology and Optometry

Vienna, State of Vienna, 1090, Austria

Location contact

Gregor S. Reiter, MD, PhD, BA, MSc

CONTACT

[email protected]

+43 1 40400 73419

Gregor S. Reiter, MD, PhD, BA, MSc

PRINCIPAL_INVESTIGATOR

Johannes Schrittwieser, MD

CONTACT

[email protected]

+43 1 40400 73557

Johannes Schrittwieser, MD

SUB_INVESTIGATOR

Markus Schranz, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Uncomplicated bilateral cataract surgery for age-related cataract within the last 2-7 days
  • Implantation of the same type of lens in both eyes (diopters may differ).
  • Age 45-99 years
  • Willingness to complete the study
  • Signed informed consent form

Exclusion criteria

  • Bilateral cataract due to a different cause
  • Retinal findings affecting quality of life or visual acuity in any eye
  • History of uncontrolled glaucoma in any eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
  • Active or suspected ocular or periocular infection in the study eye.
  • Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye.

Treatment and study plan

LACRIFILL® Canalicular Gel administration

Device

LACRIFILL® Canalicular Gel is a crosslinked hyaluronic acid hydrogel administered intracanalicularly into the lower canaliculus. Approximately 0.2 mL is administered as a single application to the randomized treatment eye to achieve temporary occlusion of the lacrimal drainage system.

Sham lacrimal canalicular procedure

Procedure

Lacrimal irrigation performed as a sham procedure in the control eye without administration of LACRIFILL® Canalicular Gel or temporary canalicular occlusion.

Primary outcomes

  1. Inter-eye difference in Schirmer Test 1 at month 1

    Time frame: 1 months

    Difference in Schirmer Test I tear production between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 month after cataract surgery. Schirmer Test I measures tear production as the length of wetting of a standardized filter paper strip over 5 minutes, expressed in millimeters (mm). Values for each eye range from 0 to 35 mm, with higher values indicating greater tear production. The inter-eye difference is calculated as the Schirmer Test I value in the Lacrifill-treated eye minus the value in the standard-of-care eye, resulting in a possible range of -35 to +35 mm. Positive values indicate greater tear production in the Lacrifill-treated eye.

Secondary outcomes

  1. Inter-eye difference in Schirmers Test 1 at month 3

    Time frame: 3 Months

    Difference in Schirmer Test I tear production between the Lacrifill-treated eye and the contralateral standard-of-care eye at 3 month after cataract surgery. Schirmer Test I measures tear production as the length of wetting of a standardized filter paper strip over 5 minutes, expressed in millimeters (mm). Values for each eye range from 0 to 35 mm, with higher values indicating greater tear production. The inter-eye difference is calculated as the Schirmer Test I value in the Lacrifill-treated eye minus the value in the standard-of-care eye, resulting in a possible range of -35 to +35 mm. Positive values indicate greater tear production in the Lacrifill-treated eye.

  2. Inter-eye difference in Oxford grading at month 1 and months 3

    Time frame: 1 month, 3 months

    Difference in ocular surface staining between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 and 3 months after cataract surgery, assessed using the Oxford Scheme for Ocular Surface Staining. The Oxford score ranges from 0 to 5 for each eye, with higher scores indicating greater ocular surface staining and therefore a worse outcome. The inter-eye difference is calculated as the Oxford score in the Lacrifill-treated eye minus the score in the standard-of-care eye, resulting in a possible range of -5 to +5. Negative values indicate less ocular surface staining, and therefore a better outcome, in the Lacrifill-treated eye.

  3. Inter-eye difference in tear break up time (TBUT) at month 1 and 3

    Time frame: 1 month; 3 months

    Difference in Tear Film Break-Up Time (TBUT) between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 and 3 months after cataract surgery. TBUT is measured in seconds and represents the time between a complete blink and the first appearance of a break in the tear film. Higher TBUT values indicate greater tear film stability and therefore a better outcome. The inter-eye difference is calculated as the TBUT in the Lacrifill-treated eye minus the TBUT in the standard-of-care eye; positive values indicate greater tear film stability in the Lacrifill-treated eye.

  4. Non-invasive tear break-up time measured with the MS-39 at Months 1 and 3

    Time frame: 1 month; 3 months

    Tear film stability will be assessed using the first non-invasive tear break-up time (NIBUT) measured with the MS-39 anterior segment analyzer (CSO, Florence, Italy). The integrated Placido disk-based tear film analysis detects the time from the last blink to the first detected disruption of the tear film. NIBUT is recorded in seconds. Higher values indicate greater tear film stability and therefore a better outcome. Measurements will be performed separately in the Lacrifill-treated eye and the contralateral sham-treated eye.

  5. Halo/glare size measured with the Real Artificial Lens Vision (RALV) system

    Time frame: 1 month and 3 months

    Halo/glare size will be quantitatively assessed using the Real Artificial Lens Vision (RALV) halo/glare test. Participants view a central white light source while optotypes are presented at decreasing radial distances from the light source. Halo/glare size is recorded as angular extent in milliradians (mrad). Higher values indicate a larger halo/glare phenomenon and therefore greater visual disturbance. Measurements will be performed separately for the Lacrifill-treated eye and the contralateral sham-treated eye.

  6. Outcomes of questionnaires

    Time frame: 1 month; 3 months

    Report of the dry eye disease questionnaires (OSDI and SPEED) and the National Eye Institute Visual function questionnaire 25 at month 1 and 3

  7. Number of applied artifical tear drops

    Time frame: 3 months

    Self-reported number of average applications of artificial tear drops per eye per day.

  8. Incidence of adverse events and device- or procedure-related adverse events

    Time frame: 3 months

    Incidence, nature, severity, and relationship to the investigational device and/or procedure of adverse events, including serious adverse events and serious adverse device effects.

  9. Inter-eye difference in visual quality assessment

    Time frame: 1 month; 3 months

    Difference in Visual quality assessment measured by Refractive Artificial Lens Vision (RALV) at month 1 and 3

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery in a Prospective Randomized Controlled Inter-eye Study

Acronym: TANAMI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 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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