NCT07581548

Brief Summary

The primary objective of this study is the assessment of three tear substitute formulations in terms of postoperative discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
May 2026May 2027

Study Start

First participant enrolled

May 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

CataractDry Eye

Keywords

dry eyecataract surgerysodium hyaluronateartificial tears

Outcome Measures

Primary Outcomes (2)

  • Ocular Surface Disease Index (OSDI)

    A subjective parameter that quantifies corneal discomfort

    12 weeks

  • Tear Break-up Time (TBUT)

    An objective parameter that quantifies stability of tear film

    12 weeks

Secondary Outcomes (2)

  • Schirmer test (basal tear production)

    12 weeks

  • Efron scale for bulbar redness

    12 weeks

Study Arms (3)

Study Group 1

Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)

Drug: Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)

Study Group 2

Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)

Drug: Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)

Study Group 3

Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)

Drug: Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)

Interventions

Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)DRUG

Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen

Study Group 1
Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)DRUG

Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Trehalose 3% quid in their postoperative regimen

Study Group 2
Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)DRUG

Cataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen

Study Group 3

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent cataract extraction surgery

You may qualify if:

  • Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale

You may not qualify if:

  • Former incisional surgery
  • Former diagnosis of corneal disease
  • Autoimmune diseases
  • Mental diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (2)

  • Labiris G, Ntonti P, Sideroudi H, Kozobolis V. Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2017 May 10;4:13. doi: 10.1186/s40662-017-0079-5. eCollection 2017.

    PMID: 28497070BACKGROUND

  • Ntonti P, Panagiotopoulou EK, Karastatiras G, Breyannis N, Tsironi S, Labiris G. Impact of 0.1% sodium hyaluronate and 0.2% sodium hyaluronate artificial tears on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2019 Feb 11;6:6. doi: 10.1186/s40662-019-0131-8. eCollection 2019.

    PMID: 30805405BACKGROUND

MeSH Terms

Conditions

CataractDry Eye Syndromes

Interventions

Hyaluronic AciddexpanthenolTrehalose

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesLacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesGlucansDisaccharidesOligosaccharidesSugars

Study Officials

  • Georgios Labiris, MD, Prof

    Democritus University of Thrace

    STUDY CHAIR

Central Study Contacts

Eirini - Kanella Panagiotopoulou, MD, MSc, PhD

CONTACT

+30 6978730858panagiotopoulou.ek@gmail.com

Georgios Labiris, MD, Prof

CONTACT

+30 2551030990labiris@usa.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations

GR(1)