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NCT Number: NCT07711561

Simple Non-cultured Endothelial Cell Therapy for Corneal Endothelial Dysfunction

Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

L V Prasad Eye Institute

Hyderabad, Telangana, 500034, India

Location status: Recruiting

Location contact

Sunita Chaurasia

CONTACT

[email protected]

9396475020

Sunita Chaurasia

PRINCIPAL_INVESTIGATOR

About this study

The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving cell injection therapy generated from non-cultured human corneal endothelial cells. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from irreversible post-surgical corneal decompensation, specifically, all forms of pseudophakic or aphakic bullous keratopathy.

Exclusion criteria

  • Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I.
  • Patients with complex anterior segment complications precluding a successful SNEC-I procedure
  • Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation
  • Post-laser iridotomy or glaucoma related corneal decompensation
  • Patients not keen to participate in the clinical trial
  • Patients who are below 21 years of age or above 80 years of age
  • Patients who are pregnant
  • Patients who are cognitively impaired
  • Patients who are prisoners
  • Patients with antibiotics/antimycotics allergies

Treatment and study plan

cell injection

Biological

Direct endothelial cell injection of non-cultured corneal endothelial cells

Primary outcomes

  1. BSCVA

    Time frame: 1, 3, 6, 12 months post-operatively

    Snellen best spectacle-corrected visual acuity (BSCVA). The Snellen BSCVA will be converted to logarithm of the minimum angle of resolution visual acuity for statistical analysis.

Secondary outcomes

  1. Autokeratorefractometer

    Time frame: 1, 3, 6, and 12 months post-operatively

    Keratometric astigmatism and spherical equivalent: will be measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)

  2. Intraocular pressure

    Time frame: 1, 3, 6 and 12 months post-operatively

    Intraocular pressure: will be measured by a noncontact tonometry (CT-60; Topcon)

  3. Endothelial Cell Density

    Time frame: 1, 3, 6 and 12 months post-operatively

    Endothelial cell density (ECD): will be measured by a noncontact specular microscope (Konan Medical Corp, Hyogo, Japan). The ECD data will be expressed as percentage of cell loss compared with the donor ECD

  4. Graft thickness

    Time frame: 1, 3, 6 and 12 months post-operatively

    Graft thickness: will be measured by ASOCT (Visante OCT, Carl Zeiss Meditec)

  5. Contrast Sensitivity

    Time frame: 6, 12 months post-operatively

Sponsors and collaborators

Lead sponsor

Singapore Eye Research Institute

Other

Collaborators

  • L.V. Prasad Eye Institute

Registry information

Official study title

Safety and Efficacy of Simple Non-cultured Endothelial Cell Injection(SNEC-I) Therapy for Corneal Endothelial Dysfunction

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 17, 2026
Registry last updated
Jul 17, 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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