NCT04591587

Brief Summary

CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

June 15, 2020

Last Update Submit

February 15, 2024

Conditions

Keratoconus

Keywords

KeratoconusSmall IncisionFresh LenticuleStromal ImplantationStromal Stem CellsSmile Surgery

Outcome Measures

Primary Outcomes (1)

  • Increase of corneal thickness at patients Lenticule group

    Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes

    12 months

Secondary Outcomes (1)

  • Improvement of visual acuity at patients Lenticule group

    12 months

Study Arms (2)

Smile Group

ACTIVE COMPARATOR

Twenty patients (20) underwent SMILE surgery (first group)

Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery

Lenticule Group

ACTIVE COMPARATOR

Twenty patients (20) underwent lenticule implantation (second group)

Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery

Interventions

Lenticule Implantation in Keratoconus Disease with RELEX Smile SurgeryPROCEDURE

Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery using VisuMax Femtosecond laser- Smile module surgery with primary objective to increase central corneal thickness and secondary objective to improve visual acuity and reduces K-values

Lenticule GroupSmile Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients clinically diagnosed with progressive keratoconus

You may not qualify if:

  • Active anterior segment pathologic features, Corneal thickness over 420, Previous corneal or anterior segment surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Both models participated in this study. Model ages were from 20 up to 45
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Doctor

Study Record Dates

First Submitted

June 15, 2020

First Posted

October 19, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

December 15, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

KO(1)