PROTOCOL

Purpose

The long-term goals of the European Cataract Outcome
Study Group are:

- to reflect the outcome of routine medical care in Europe concerning cataract surgery

- to form a European basis for quality assurance of cataract surgery at individual departments in different countries

- to promote quality improvement and provide a benchmarking for comparing and demonstrating good practice

- to stimulate the diffusion of good technology in cataract surgery care

- to monitor the availability of cataract surgery in different European countries

- to improve knowledge concerning the appropriate indications and optimal time for surgery by evaluating benefits that patients experience from surgery.
 

Study Group Chairman
Mats Lundström, EyeNet Sweden, Blekinge Hospital, SE- 371 85 Karlskrona, Sweden.
 

Management Group
Peter Barry, The Eye Clinic, 33 Herbert Avenue, Merrion Road, Dublin 4, Ireland

Conceiçāo Lobo, Department of Ophthalmology, University Hospital of Coimbra, Praceta Mota Pinto, 3000 Coimbra, Portugal

Ulf Stenevi, Department of Ophthalmology, Sahlgren’s University Hospital,
SE-431 80 Mölndal, Sweden.

Ype Henry, Department of Ophthalmology, AZVU, De Boelelaan 1117, Postbus 7057,     1007 MB Amsterdam, Holland.
 

Governing Body
Blekinge County Council, Blekinge Hospital, SE-371 85 Karlskrona.
 

 Participating Units and performed studies
Interested surgeons or clinics are invited to participate in each study period.

During the first study period, November 1^st 1995 – April 30^th 1996, 20 clinics/surgeons from 11 countries participated. The number of patients included in the study was 1594.

During the second study period, March 1^st 1997 – September 30^th 1997, 24 clinics/surgeons from 11 countries participated. The number of patients included in the study was 1688.

During the third study period, October 1^st 1998 - April 30^th 1999, 31 clinics/surgeons from 13 countries participated. The number of patients included in the study was 2959.

During the fourth study period, October 1^st 1999 - April 30^th 2000, 41 clinics/surgeons from 15 countries participated. The number of patients included in the study was 3245.

During the fifth study period, October 1^st 2000 - April 30^th 2001, 39 clinics/surgeons from 18 countries participated. The number of patients included in the study was 3944

During the sixth study period, October 1^st 2001 – April 30^th 2002, 37 clinics/surgeons from 19 countries participated. The number of patients included in the study was 4303.

During the seventh study period, October 1^st 2002 – April 30^th 2003, 42 clinics/surgeons from 21 countries participated. The number of patients included in the study was 5353.

During the eighth study period, October 1^st 2003 – April 30^th 2004, 45 clinics/surgeons from 21 countries participated. The number of patients included in the study was 5451.

During the ninth study period, October 1^st 2004 – April 30^th 2005, 40 clinics/surgeons from 21 countries participated. The number of patients included in the study was 4578.

During the tenth study period, October 1^st 2005 – April 30^th 2006, 38 clinics/surgeons from 20 countries participated. The number of patients included in the study was 4039.

During the eleventh study period, October 1^st 2006 – April 30^th 2007, 35 clinics/surgeons from 15 countries participated. The number of patients included in the study was 3983.

During the 12th study period, October 1^st 2007 – April 30^th 2008, 64 clinics/surgeons from 17 countries participated. The number of patients included in the study was 3561.

Actual study
From October 1^st 2008 – April 30^th 2009.

Sponsors
ESCRS: www.escrs.org

The Swedish National Board of Health and Welfare: www.sos.se

Swedish Association of Local Authorities and Regions: www.skl.se

Blekinge County Council:  www.ltblekinge.se
 

 Application to the Data Inspection Board
The registry of cataract surgery patients in a database with the actual variables has been accepted by the Swedish Data Inspection Board.
 

 Informed Consent Requirements of the Data Inspection Board
According to the Data Inspection Board’s requirements patients included in the study shall be informed about the study.
 

 Application for Ethical Appraisal
The application has been submitted to an ethics committee at Blekinge Hospital in Sweden. The committee has accepted the study program.
 

 Criteria for inclusion
The period of surgery to be included in the study is presently one month. All cataract extractions performed during the month of October in the participating unit should be included. Cataract extractions combined with other surgical procedures like filtering operation or corneal transplantation should be included. Secondary implantation of an IOL in an eye previously operated for cataract should not be included.
 

 Variables registered
The variables are listed on two forms, Register Form and Follow Up Form.
 

 Instructions to Participating Units
There is a written manual about how to do measurements and how to fill out the forms.
 CATARACT MANUAL
 

 Endpoints for follow-up
The endpoint of follow-up is six months after surgery. This means that forms should be completed at the latest six months after surgery. Normally, for each patient, the study period is finished when the final visit after surgery has occurred.
 

 Control Functions, Validation
There are a number of computer-based controls.

- Visual acuity will only be accepted in the range 0.1 – 1.0

- K-values will only be accepted between 35 and 55 diopters

- Date of surgery will always be higher than date on waiting list

- Date of final visit will always be higher than date of surgery

- Date of surgery must be in the study month

- Only one response option is accepted in ‘Type of surgery’ and ‘Type of IOL’.
 

 Planned reports
Written standard reports

After the study period each Unit/Participant will receive the results for the study.

Standard reports can be achieved from the web site.

- data for the actual Unit/Participant

- aggregated data for all participating Units during the study period

Meetings
The result of a study period should be reported to the European Cataract Outcome Study Group at the next forthcoming meeting in the ESCRS. A special meeting during the congress should be organized for this purpose.

Scientific reports.
Relevant scientific reports can be produced. If so, all participants in the study should have their names on the report, either as co-authors or in the Acknowledgement.

Publications
Lundström M, Barry P, Leite E, Seward H, Stenevi U. 1998 European Cataract Outcome Study. Report from the European Cataract Outcome Study Group. J Cataract Refract Surg 2001; 27:1176-1184.

Revised:2008-11-06