Condition category
Eye Diseases
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
18/01/2007
Prospective/Retrospective
Prospectively 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

Dr D Croonen

ORCID ID

Contact details

University Medical Center Groningen (UMCG)
Department of Ophthalmology
P.O. Box 30.001
Groningen
-
Netherlands
+31 (0)50 361 2510
d.croonen@ohk.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Optimum timing of surgery for macula off rhegmatogenous retinal detachment can be determined in more detail by taking both duration and height of macular detachment into account.

Ethics approval

Approval received from the local ethics committee (Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen [METc UMCG]) on the 11th July 2006 (ref: 12551).

Study design

Non-randomised prospective observational study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Rhegmatogenous retinal detachment

Intervention

Vitreoretinal surgery according to current practice guidelines.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Visual acuity in relation to duration and height of macular detachment
2. Individual parameters relating to visual function, subjective contentness and morphology of the macula in relation to each other, duration and height of macular detachment

Primary study group:
Pre-operative and postoperative at one, three, six and 12 months.

Secondary study group:
Pre-operative and one year after the latest vitreoretinal surgery.

Secondary outcome measures

1. Correlation between height macular detachment measured by ultrasonography and by optical coherence tomography
2. Relationship between subjective contentness in the primary and secondary study groups

Overall trial start date

01/02/2007

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Primary study group:
1. Rhegmatogenous retinal detachment with macula off during one day to six weeks
2. Retinal reattachment after one surgical intervention
3. No redetachment during the study period (one year)

Secondary study group:
Same as primary study group, but more than one vitreoretinal surgical procedure is needed to obtain retinal attachment.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

1. Pre-existent ocular pathology in the study or fellow eye that significantly influences visual acuity
2. History of retinal detachment in the study or fellow eye

Recruitment start date

01/02/2007

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen (UMCG)
Groningen
-
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

Department of Ophtalmology
P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Research organisation

Funder name

Dutch Foundation of Ophthalmologic Research (Stichting Nederlands Oogheelkundig Onderzoek) (The Netherlands)

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