The National Cataract Surgery Registry

NCSR

INSTRUCTION MANUAL

(Edition 1, July 2002)

NCSR

C/O Clinical Research Centre (CRC)

3rd Floor, Block Dermatology,

Hospital Kuala Lumpur

50586, Kuala Lumpur.

Tel.: 603-26906263

Fax: 603-26911682

Email:

Web site: www.crc.gov.my/ncsr/

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INSTRUCTION MANUAL

National Cataract Surgery Registry

Introduction

The National Cataract Surgery Registry (NCSR), a Ministry of Health (MOH) supported service, collects information about cataract surgeries in Malaysia. This information will be analysed and published in annual reports available to MOH, all participating centres and other users. The information is needed for the estimation of cataract surgery treatment rates, and to evaluate cataract surgery outcomes in the country.

Objectives:

1.  To determine the frequency (cataract surgery rate) and distribution of cataract surgery in Malaysia. These are useful measures of the health burden arising of cataract and its treatment provision in the country.

2.  To determine the outcomes, and factors influencing outcomes of cataract surgery. This serves the needs of outcome assessment.

3.  To evaluate cataract surgery services. This serves the need of accountability.

4.  To stimulate and facilitate research on cataract and its management.

Sponsors

The NCSR is co-sponsored by:

1.  Ophthalmology service, MOH

2. Clinical Research Centre (CRC), MOH

Governing Body

The NCSR is governed by an advisory committee, consisting of Director of Development Division Hospital Services Department Ministry of Health, Ophthalmologist from public, universities and private hospitals and Private Eye clinics, and doctors from the Clinical Research Centre.

Participating Centre

1.  MOH Ophthalmology Departments.

2.  Army Hospitals.

3.  University Hospitals.

4.  Private Ophthalmologists / Hospitals.

Requirement of Participating Centres

Participating centres should have a doctor in charge and a site coordinator to coordinate the data collection process and communicate with data manager at CRC.

Personnel:

a) Doctor in charge: her/his duties areas are to:

  1. Give a briefing to new doctors and paramedical staff about the National Cataract Surgery Registry as stated in this manual.
  2. Ensure and monitor that the data collection process follow the methodology as stated in the instruction manual.
  3. Emphasize to doctors about the nature of ‘carbon’ on the Case Report Forms (CRF). The carbon is on the first page of CRF. Thus when filling in the back page section 4 and 5 of Pre- Clerking form and section 3 and 4 of Operative Record, please separate or put a paper between the pages.
  4. Ensure the eligibility of writing.

b) Site Coordinator (Paramedics) whose duties are to:

  1. Request Clinical Record Forms (CRF) from data manager of NCSR.
  2. Ensure that CRFs are adequate for continuous data collection. (At least 100 set in stock).
  3. Check that the data are complete before sending to Cataract Surgery Registry Unit at CRC.
  4. Counter check completed CRF with the operation list or operation record book before sending them to NCSR.
  5. Send the completed CRF (3 forms together) to CRC (address to Data Manager) at a regular period, i.e. one month after the cataract outcome (green form) is filled. .

E.g. CRF for cataract surgery, which was done in the month of January, should be submitted to NCSR by the end of May.

Participating Patients

Inclusion Criteria:

  1. All patients who undergo cataract surgery.
  2. Cataract extractions combined with other surgical procedures such as:

i.  Pterygium surgery

ii.  Filtering surgery

iii.  Vitreo-retinal surgery

iv.  Penetrating Keratoplasty

v.  Any other ophthalmic procedure.

Exclusion Criteria:

1.  Patients who need to have lens removal, decided (“on the table”) by surgeons while performing the surgeries, usually Vitreo- retinal surgery.

2.  Secondary implantation of an intraocular lens in an eye previously operated for cataract before the year 2002.

Case Record Forms (CRF)

Example of CRF is in appendix 1

Data definition

Definition of all the variables is in Appendix 2

Data Collection Process

The data collection process of the registry is incorporated into the routine clinical work process in the individual Eye Department.

  1. Pre-clerking Records (Blue Form)

1.1.  To be filled in on the day of preclerking , patients information needed for the registry are:-

·  Hospital/clinic

·  Data of pre-clerking

·  Patient particulars

·  Medical history-

o  Surgery on -First or Second eye

o  Prior Intraocular surgery

o  Cause of cataract

o  Ocular Co-morbidity

o  Systemic Co-morbidity

·  Visual Acuity Measurement

1.2.  Only the first page needs to be returned to the cataract surgery registry unit (CSRU) at CRC.

  1. Operative Record (Red Form)

2.1.  The operative record is filled in after the surgery. The information needed for the registry are:-

·  Hospital/clinic

·  Patient Name

·  I/C No

·  Operative Data

o  Surgery.

o  Type of anaesthesia

o  IOL.

·  Findings- Intra - Operative Complication.

2.2.  Only the first page required by NCSR.

  1. Cataract surgery outcomes through 12 weeks post-op . (Green Form)

It is filled in on the last follow-up visit or by 10- 14 weeks post-operation. The information needed is:

  1. Post op complication as it occurs at any time during the post-operative period till 14 weeks.
  2. Fill in the unaided and refracted visual acuity at 12+/- 2 weeks .
  3. Record of refractive status in dioptre, e.g. 1.00/2.0 x 90° is optional.
  4. If visual acuity at 12(+/-2) weeks is not available either because patient has been lost for follow-up or patient has been discharged by doctor, fill in visual acuity at second row in section 2 and state the reason why visual acuity at 12+-2 weeks is not available in the third row.(Refer Green form).
  5. The maximum endpoint of follow-up is 14 weeks after surgery. This means that forms should be completed at the latest 14 weeks after surgery and send back to CSRU soon after that. However, there is no minimum end point, i.e. green form can be completed at any stage of post-operative period when the doctors feel that patients can be discharged because of stable good visual acuity (better than 6/12) even though it is before 14 weeks. .

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Data collection clarification in some exceptional cases

Scenario 1.

Patient who had complicated cataract operation where IOL was not inserted The same patient then underwent a second operation for IOL implantation on the same eye.

e.g. Rt. eye

1st operation - Rt ECCE without IOL implantation on 12/01/02 followed by

2nd operation -Rt. 2° 10L implantation on14/03/02.

Therefore CRF to be sent to NCSR are:

Pre clerking record and - Operative record for the 1ST Operation and Operative record of the 2nd operation and Cataract surgery outcome 12+/- 2 weeks after the 2nd operation.

Scenario 2.

The same patient had cataract operations on both the eyes

e.g. 1st eye Rt. ECCE / 10L done on 15/01/02.

2nd eye Lt. ECCE / 10L done on 17/01/02.

Therefore two separate sets of CRF should be sent to NCSR.

1st Eye

-  Pre clerk Record

-  Operative Record

-  Cataract Surgery Outcome

2nd Eye. (Separate set of CRF)

-  Pre clerk Record

-  Operative Record

-  Cataract Surgery Outcome.


Further Information: Contact ® SN LEE POE POAY

Data Manager

Address: National Cataract Surgery Registry (NCSR)

Cataract Surgery Registry Unit (CSRU)

C/O Clinical Research Centre (CRC)

3rd Floor, Block Dermatology,

Hospital Kuala Lumpur

50586, Kuala Lumpur.

Tel.: 603-26906263

Fax: 603-26911682

Email:

OR Visit Cataract Surgery Registry Website: http://www.crc.gov.my/ncsr/

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APPENDIX 1

CASE REPORT FORM (CRF)

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APPENDIX 2
DATA DEFINITION

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