Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Alonso Rodriguez

ORCID ID

Contact details

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0141109873

Study information

Scientific title

Prospective comparison of Laser Assisted In Situ Keratomileusis (LASIK) using one and two step ablation for the correction of refractive errors after penetrating keratoplasty

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Keratomileusis

Intervention

Comparison of 2 methods of LASIK surgery:
1. One step (flap cut and immediate laser ablation)
2. Sequential (flap cut and delayed laser ablation, 1 month later) LASIK treatment

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

To compare the safety and predictability of one step (flap cut and immediate laser ablation) and sequential (flap cut and delayed laser ablation, 1 month later) LASIK treatment for post-PK-myopic spherical error

Secondary outcome measures

Not provided at time of registration

Overall trial start date

25/04/2002

Overall trial end date

25/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

25/04/2002

Recruitment end date

25/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Moorfields Eye Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes