NCT00850148

Brief Summary

This study will be performed on patients who come to labbafinejad ophthalmic clinic from 20 March 2008. Keratoconus diagnosis will be determined by clinical finding in slit lamp, keratometery and topographic characteristics. Patients will be randomly placed in group A and B. In group A, Anwar surgical method and in B, Melles surgical method, will be done. This is not a blind study due to surgeons' knowledge. All patients will receive Btamethazone drop and Chloramphenicol every 6 hours and will be tapered in two months. In the end anatomical results, complications, BCVA, UCVA, astigmatism, endothelial cell numbers will be compared in two groups by using specular microscopy. Contrast sensivity, central corneal diameter, interface wrinkling and opacity will be measured by metrovison, Confoscan, Photoslit in months 3, 6, 12, respectively and will be evaluated afterwards.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2008

Geographic Reach
1 country

2 active sites

Status
completed

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

May 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 5, 2012

Status Verified

February 1, 2009

Enrollment Period

1.1 years

First QC Date

February 23, 2009

Last Update Submit

January 4, 2012

Conditions

Keywords

AnwarMellesKeratoconus

Study Arms (2)

Melles

EXPERIMENTAL
Procedure: Melles

Anwar

EXPERIMENTAL
Procedure: Anwar

Interventions

AnwarPROCEDURE

Anwar surgical method

Anwar
MellesPROCEDURE

Melles surgical method

Melles

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with keratoconus
  • \<age\<45
  • contact lens intolerance

You may not qualify if:

  • Having a history of any other ophthalmic or systemic problem
  • Central corneal scar
  • descemet's membrane detachment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ophtalmic Research Centre

Tehran, Tehran Province, 1666663111, Iran

Location

Farid Karimian,MD

Tehran, Tehran Province, 166666, Iran

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

January 5, 2012

Record last verified: 2009-02

Locations