NCT00371202

Brief Summary

it is a randomized clinical trial to compare deep lamellar keratoplasty (DLK) Using big bubble technique and Penetrating Keratoplasty (PK) in patients with keratoconus

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Last Updated

January 15, 2007

Status Verified

January 1, 2007

First QC Date

August 31, 2006

Last Update Submit

January 12, 2007

Conditions

Keratoconus

Keywords

keratoconus, penetrating keratoplasty,deep lamellar keratoplastybig bubble technique

Outcome Measures

Primary Outcomes (1)

  • Uncorrected visual acuity (UCVA), best corrected visual acuity(bcva), refractive astigmatism, endothelial cell density, mean cell area, polymegathism (CV), Contrast sensitivity, Root-mean-square (RMS) Wavefront error, Pearson correlation factor between

Interventions

keratoplastyPROCEDURE

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • moderate to severe keratoconus
  • contact lens intolerance
  • low visual acuity due to anterior stromal scar
  • age between 15 to 50 years

You may not qualify if:

  • posterior stromal scar with descemets membrane involvement
  • history of hydrops
  • fuchs endothelial dystrophy
  • glaucoma
  • cataract
  • history of intraocular surgery
  • history of vernal keratoconjunctivitis
  • intraoperative complications
  • reoperation (resuturing- regraft)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahram Einollhi, MD

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Transplantation

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Bahram Einollahi, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

July 1, 2006

Study Completion

August 1, 2006

Last Updated

January 15, 2007

Record last verified: 2007-01

Locations

IR(1)