Following Patients After Selective and Pascal Laser Trabeculoplasty for Treatment of Chronic Open-Angle Glaucoma

Glaucoma, Open-Angle Clinical Trial

— FPSPLTTCOAG  

Official title:

Following Patients After Selective and Pascal Laser Trabeculoplasty for Treatment of Chronic Open-Angle Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02679482
• Other study ID #: FONCI6001
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2016
• Last updated: February 13, 2016
• Start date: September 2014
• Est. completion date: October 2016

Study information

• Verified date: February 2016
• Source: Fundación Oftalmológica Nacional
• Contact: Claudia Carvajal
• Phone: +57-311-856-4991
• Email: crcarvajal[@]fon.org.co
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Subjects of either sex, aged = 40 years

• Best distant visual acuity, better than or equal to 20/200

• Diagnosis of primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma, with open angles by Posner lens gonioscopy

• Intraocular pressure = 20 mmHg, with medical treatment, as monotherapy or combination therapy.

• Previous computerized visual field within the six months previous performing trabeculoplasty

• Patients who understand and sign the informed consent

• Patient diagnosed with open-angle glaucoma who will undergo selective laser trabeculoplasty (SLT) with an amplitud of 360 degrees, or laser trabeculaplastia in pattern (PASCAL-Pattern Scan Laser) with an amplitud of 360 degrees. Made at initial session or in two 7 days separate sessions (each with session with an amplitude of180 degrees)

Exclusion Criteria:

• Advanced loss on visual field within 10 degrees of central fixation in a previous 3 months visual field

• Previous history of surgery for glaucoma management, except peripheral iridotomy

• Corneal disease that does not allow the use of applanation tonometer nor an accurate measurement of intraocular pressure

• Corneal disease which prevents adequate visualization of trabeculo by gonioscopy lens

• Use of topical or systemic steroids

• Concomitant participation in another study

• Coexistence of other ocular pathology different than cataract.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exfoliation Glaucoma
• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Pigmentary
• Glaucoma, Primary Open Angle

Locations

Country	Name	City	State
Colombia	Fundacion Oftalmológica Nacional	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Oftalmológica Nacional

Country where clinical trial is conducted

Colombia, 

References & Publications (18)

Alvarado JA, Alvarado RG, Yeh RF, Franse-Carman L, Marcellino GR, Brownstein MJ. A new insight into the cellular regulation of aqueous outflow: how trabecular meshwork endothelial cells drive a mechanism that regulates the permeability of Schlemm's canal endothelial cells. Br J Ophthalmol. 2005 Nov;89(11):1500-5. — View Citation

Barkana Y, Belkin M. Selective laser trabeculoplasty. Surv Ophthalmol. 2007 Nov-Dec;52(6):634-54. Review. — View Citation

Bradley JM, Anderssohn AM, Colvis CM, Parshley DE, Zhu XH, Ruddat MS, Samples JR, Acott TS. Mediation of laser trabeculoplasty-induced matrix metalloproteinase expression by IL-1beta and TNFalpha. Invest Ophthalmol Vis Sci. 2000 Feb;41(2):422-30. — View Citation

Buys YM. Economics of selective laser trabeculoplasty as primary therapy for glaucoma. Can J Ophthalmol. 2006 Aug;41(4):419-20. — View Citation

Bylsma SS, Samples JR, Acott TS, Van Buskirk EM. Trabecular cell division after argon laser trabeculoplasty. Arch Ophthalmol. 1988 Apr;106(4):544-7. — View Citation

Krasnov MM. [Laser puncture of the anterior chamber angle in glaucoma (a preliminary report)]. Vestn Oftalmol. 1972;3:27-31. Russian. — View Citation

Latina MA, Park C. Selective targeting of trabecular meshwork cells: in vitro studies of pulsed and CW laser interactions. Exp Eye Res. 1995 Apr;60(4):359-71. — View Citation

Pham H, Mansberger S, Brandt JD, Damji K, Ramulu PY, Parrish RK. Argon laser trabeculoplasty versus selective laser trabeculoplasty. Surv Ophthalmol. 2008 Nov-Dec;53(6):641-6. doi: 10.1016/j.survophthal.2008.08.020. — View Citation

Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30. Review. — View Citation

Sambhara D, Aref AA. Glaucoma management: relative value and place in therapy of available drug treatments. Ther Adv Chronic Dis. 2014 Jan;5(1):30-43. doi: 10.1177/2040622313511286. Review. — View Citation

Samples JR, Singh K, Lin SC, Francis BA, Hodapp E, Jampel HD, Smith SD. Laser trabeculoplasty for open-angle glaucoma: a report by the american academy of ophthalmology. Ophthalmology. 2011 Nov;118(11):2296-302. doi: 10.1016/j.ophtha.2011.04.037. Epub 2011 Aug 17. — View Citation

Sanghvi C, McLauchlan R, Delgado C, Young L, Charles SJ, Marcellino G, Stanga PE. Initial experience with the Pascal photocoagulator: a pilot study of 75 procedures. Br J Ophthalmol. 2008 Aug;92(8):1061-4. doi: 10.1136/bjo.2008.139568. Epub 2008 Jun 27. — View Citation

The Glaucoma Laser Trial (GLT). 2. Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group. Ophthalmology. 1990 Nov;97(11):1403-13. — View Citation

Van Buskirk EM, Pond V, Rosenquist RC, Acott TS. Argon laser trabeculoplasty. Studies of mechanism of action. Ophthalmology. 1984 Sep;91(9):1005-10. — View Citation

Wang H, Cheng JW, Wei RL, Cai JP, Li Y, Ma XY. Meta-analysis of selective laser trabeculoplasty with argon laser trabeculoplasty in the treatment of open-angle glaucoma. Can J Ophthalmol. 2013 Jun;48(3):186-92. doi: 10.1016/j.jcjo.2013.01.001. Review. — View Citation

Wang W, He M, Zhou M, Zhang X. Selective laser trabeculoplasty versus argon laser trabeculoplasty in patients with open-angle glaucoma: a systematic review and meta-analysis. PLoS One. 2013 Dec 19;8(12):e84270. doi: 10.1371/journal.pone.0084270. eCollection 2013. Review. — View Citation

Wise JB, Witter SL. Argon laser therapy for open-angle glaucoma. A pilot study. Arch Ophthalmol. 1979 Feb;97(2):319-22. — View Citation

Zhao JC, Grosskreutz CL, Pasquale LR. Argon versus selective laser trabeculoplasty in the treatment of open angle glaucoma. Int Ophthalmol Clin. 2005 Fall;45(4):97-106. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	The eye pressure measured in millimeters of mercury, measure with Goldman tonometer at follow-up period	Six months	Yes

External Links

•   A new insight into the cellular regulation of aqueous outflow: how trabecular meshwork endothelial cells drive a mechanism that regulates the permeability of Schlemm's canal endothelial cells
•   Argon laser therapy for open-angle glaucoma. A pilot study
•   Argon laser trabeculoplasty versus selective laser trabeculoplasty
•   Argon laser trabeculoplasty. Studies of mechanism of action
•   Argon versus selective laser trabeculoplasty in the treatment of open angle glaucom
•   Economics of selective laser trabeculoplasty as primary therapy for glaucoma
•   Glaucoma
•   Glaucoma management: relative value and place in therapy of available drug treatments
•   Initial experience with the Pascal photocoagulator: a pilot study of 75 procedures
•   Laser puncture of the anterior chamber angle in glaucoma (a preliminary report)
•   Laser trabeculoplasty for open-angle glaucoma: a report by the american academy of ophthalmology
•   Mediation of laser trabeculoplasty-induced matrix metalloproteinase expression by IL-1beta and TNFalph
•   Meta-analysis of selective laser trabeculoplasty with argon laser trabeculoplasty in the treatment of open-angle glaucoma
•   Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group
•   Selective laser trabeculoplasty
•   Selective laser trabeculoplasty versus argon laser trabeculoplasty in patients with open-angle glaucoma: a systematic review and meta-analysis
•   Selective targeting of trabecular meshwork cells: in vitro studies of pulsed and CW laser interactions
•   Trabecular cell division after argon laser trabeculoplasty