By observing several visual aspects in a large patient population we would like to obtain more information about the best time of surgical intervention (primary study group). 80% of the patients need only one surgical intervention to obtain an…
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Visual outcome in relation to time and height of detached macula
preoperatively.
2a.Postoperative morphology of the macula in relation to visual outcome,
b. Postoperative morphology of the macula in relation to subjective
satisfaction.
c. Visual outcome in relation to time and height of detached macula
preoperatively
d. Visual outcome in relation to subjective satisfaction.
3. Surgical technique in relation to rapidity of postoperative visual recovery.
4a. Frequency of developing entoptic phenomena
b. Description of entoptic phenomena developing after retinal detachment
surgery
Secondary outcome
1. correlation between height of detached macula measured with USG and OCT.
2. Visual outcome and subjective satisfaction differences between primary and
secondary study group.
Background summary
A rhegmatogenous retinal detachment is a vision-threatening disease. If the
macula is detached, chances are that visual recovery will not be complete. At
this moment, it is hard to predict preoperatively what the postoperative visual
outcome will be.
It is clear that timing of surgery influences the postoperative visual outcome;
eyes that obtained surgery within1 to 9 days of detached macula will have a
better visual outcome compared to eyes that did not obtain this surgery within
this time frame. Within these 9 days no significant differences could be found.
This is an unexpected result regarding experimental animal studies. These show
progressive changes from 1 day up to 2 weeks after induction of a retinal
detachment. A possible explanation between the discrepancy of experimental
animal studies and the observational studies on humans may be that other visual
outcome influencing factors also play a role. One explanation could be the
amount of fluid in between the neurosensory retina and its retinal pigment
epithelium (height of detached macula). This has been reported in several
studies; unfortunately we could not find a study that combines above-mentioned
factors.
Furthermore, after surgery patients mention sometimes spontaneously newly
developed entoptic phenomena. Entoptic phenomenona are visual perceptions,
produced or influenced by structures within the eye. Some of these phenomena
are not understood.
Study objective
By observing several visual aspects in a large patient population we would like
to obtain more information about the best time of surgical intervention
(primary study group). 80% of the patients need only one surgical intervention
to obtain an attached retina. The patient group with a detached retina after
one surgical intervention will have an attached retina in 95% of the cases. We
would like to observe the visual aspects of this group (secundairy study group)
separately to get an impression of the additional damage by having a second
retinal detachment and its surgical intervention.
Furthermore, we would like to get an impression of newly developed entoptic
phenomena after retinal detachment surgery by interviewing the specific
patients structurally. We hope to get a clue about the pathogeneses of the
entoptic phenomenon mentioned after retinal detachment surgery.
Study design
Prospective observational study n = 200 eyes of rhegmatogenous retinal
detachment patients, macula detached. (1 day to 6 weeks). Non-randomized
(surgical technique will be decided by surgeon). Time of surgical intervention
will be determined by the existing guidelines.
Study burden and risks
This study does not cause any risk factors for participating patients. The
preoperative ophthalmic examination will take 65 minutes longer.
Postoperatively the extra examination will be linked to regular appointments;
on 1, 6 and 12 months postoperatively, which will make these visits 122 minutes
longer. At 3 months postoperatively it will take 30 minutes longer.
postbus 30001
9700 RB
NL
postbus 30001
9700 RB
NL
Listed location countries
Age
Inclusion criteria
-first rhegmatogenous retinal detachment
-macula detached
-no other pathology that can influence visual functioning
Exclusion criteria
-indication for immediate surgery
-visual functioning influencing pathology in the affected eye
-visual functioning influencing pathology non-affected eye
-history of retinal detachment, either eye
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12551.042.06 |