Glaucoma, Open-Angle Clinical Trial
Official title:
Following Patients After Selective and Pascal Laser Trabeculoplasty for Treatment of Chronic Open-Angle Glaucoma
The purpose of this study is to follow and describe the outcomes of patients after selective and pascal laser trabeculoplasty treatment for chronic open-angle glaucoma.
Selective laser trabeculoplasty (SLT) and pattern laser trabeculoplasty (PLT, a novel
computer-guided laser that is being using to treat open-angle glaucoma) are two laser
surgery methods to make a trabeculoplasty on patients with open angle glaucoma. An
observational prospective study will be performed, a consecutive convenience sample patients
with indication for SLT or PLT will be recruited during June 2014 to uly 2016 and follow-up
until 6 months, at the Fundación Oftalmológica Nacional (Bogotá-Colombia). A
non-probabilistic convenience sampling is performed, considering that the average number of
patients diagnosed with chronic open-angle glaucoma undergoing to Laser trabeculoplasty at
the Oftalmológica Nacional Fundacion corresponds to approximate 2 per month. Therefore it is
expected to enroll one patient per month for each of the laser used (SLT and PLT) for
trabeculoplasty. Finally obtaining a sample size of 18 patients per type of laser for a
total of 36 patients in the recruitment period, between September 2014 and July 2016.
This study is strictly observational, that's why the laser procedure is covered by the
national health insurance of each patient, as well the complications due to the same
procedure. An evaluation pre trabeculoplasty and a consecutive 5 visits will be perform as
follows:
Visit 0 - Pre-procedure visit: the subjects that will undergo laser trabeculoplasty either
Selective laser or PASCAL laser will be invited to participate and an informed consent will
be carried out. The information concerting to demographics characteristics (study eye, age,
gender and ethnicity), clinical characteristics (date of glaucoma diagnosis, number of
medications used to treat glaucoma, time of use of actually anti-glaucomatous topical
medication) and slit lamp and ophthalmoscopy examination (corneal aspect, iris color, pupil
gonioscopy, intraocular pressure, lens status, vitreous cells, vertical C/D ratio, optic
nerve edge, rim characteristic [ISNT pattern], peripapilar atrophy, state of fovea, state of
peripheral retina and state of choroid for both eyes) will be extracted and recorded on
respective case report form (CRF). The data will be scored according to the grading criteria
outlined below:
Study eye: the eye under the follow-up 0 - Right eye 1 - Left eye
Geder: the state of being male or female 0 - Male 1 - Female
Ethnicity: the fact or state of belonging to a social group that has a common national or
cultural tradition.
0 - Hispanic
1. - Black
2. - White
3. - Asian
Number of medications used: anti-glaucoma medication used by the patient 0 - 0
1. - 1
2. - 2
3. - 3
4. - 4
Corneal aspect: state in which the cornea is at baseline 0 - Normal 1 - Anormal
Iris color: iris pigmentation 0 - Light
1. - Medium
2. - Dark
Gonioscopy (Shaffer classification): amplitude of irido-corneal angle maseure by poster lens
and noted by the Shaffer scale on each quadrant superior, nasal, temporal and inferor angle
0 - 0
1. - 1
2. - 2
3. - 3
4. - 4
Intraocular pressure: pressure inside the eye measured in millimeters of mercury Value in
mmhg, measure with Goldman tonometer
Lens status: clouding of the lens Nuclear, Subcapsular and Cortical 0 - 0
1. - 1
2. - 2
3. - 3
4. - 4
Vitreous cells: number of cells per milimeter in the vitreous cavity 0 - 0 1 - traces 2 - +1
3 - +2 4 - +3 5 - +4
Vertical C/D ratio: relation between cup and optic nerve disc 0 - 0.1
1. - 0.2
2. - 0.3
3. - 0.4
4. - 0.5
5. - 0.6
6. - 0.7
7. - 0.8
8. - 0.9
9. - 1.0
Optic nerve edge: regularly over the optic disc 0 - Regular
1 - Irregular
Rim characteristic [ISNT pattern]: reduction pattern in the thickness of neural ring 0 -
Conserved 1 - Not conserved
Peripapilar atrophy: presence of atrophy over the disc 0 - Alfa
1 - Beta 3 - Not apply
State of fovea: normality of the fovea 0 - normal
1 - abnormal
State of peripheral retina: state of the peripheral retina 0 - normal
1 - abnormal
State of choroid: choroidal health 0 - normal
1 - abnormal
After the visit 0, a 5 consecutive visits will be performed: for 1 day, 1 week, 1 month, 3
months and 6 months after the procedure. Identical data will be extracted, ophthalmological
examination data, slit lamp exam, and the computerized visual fields (CVF) (CVF only at 3
and 6 months).
One member of the investigation team will collect all information during the follow-up time,
and a second one member will review and collate data.
Statistical analysis will be performed in SPSS version 21. Univariate analyzes will perform;
for categorical variables, frequency distribution will be made and reported in percentage,
for the quantitative variables a measure of central tendency and dispersion will be made
(mean, standard deviation and range) will calculate according to the relevance for each
variable analyzed. Demographics such as age and gender variables will be described. For
bivariate analysis comparing polytomous qualitative and quantitative variables (evolution of
intraocular pressure with the type of trabeculoplasty used, number of antihypertensive
medications required after the procedure with the type of trabeculoplasty, quantification of
cellularity in the anterior chamber with type of trabeculoplasty) using parametric
statistical analysis with ANOVA for independent samples and nonparametric with
Kruskal-Wallis test. Also comparison of quantitative variables with quantitative variables
(intraocular pressure before treatment and evolution of intraocular pressure after
treatment) will be performed using the parametric inferential statistical Pearson
correlation analysis and for nonparametric a Spearman correlation will be made. Finally,
compare qualitative variables with qualitative variables (presence of peak intraocular
pressure with type of laser trabeculoplasty performed) using the non-parametric statistical
analysis Chi square test, Fisher exact test and Mac Nemar will make.
;
Observational Model: Case Control, Time Perspective: Prospective
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