AzTrials
AzTrials

GlaucomaSLTNCT05900063

Evaluation of the Efficacy of Selecta Laser Trabeculoplasty in Patients Undergoing Filtering Surgery

An observational study of Glaucoma, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Glaucoma is a common, potentially blinding pathology, threatening patients' autonomy and quality of life. The main aim of treatment is to lower intraocular pressure (IOP) in order to slow nerve fiber loss as much as possible, leading to alterations in the visual field and even reduced visual acuity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma
How many people
75 participants
Where
1 siteFrance
Study dates
1 Jan 2018to 15 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patient undergoind SLT with insufficiently controlled IOP after filtering surgery

Who may be able to join

  • Patients aged ≥ 18 years
  • Patients who have undergone filtering surgery such as trabeculectomy, deep non-perforating sclerectomy, or placement of a Xen®-type device
  • Patients who have undergone laser SLT
  • Patient with primary open-angle glaucoma, exfoliative glaucoma or pigmentary glaucoma
  • Insufficiently controlled intraocular pressure.
  • Exclusion Criteria: - Patients under guardianship or curatorship
Show all 10Show fewer
  • Patient deprived of liberty
  • Patient objecting to the use of his or her data for this research
  • Patient with angle-closure glaucoma
  • Patient having undergone any other type of eye surgery except cataract surgery

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Paris Saint Joseph

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

Glaucoma is a common, potentially blinding pathology, threatening patients' autonomy and quality of life. The main aim of treatment is to lower intraocular pressure (IOP) in order to slow nerve fiber loss as much as possible, leading to alterations in the visual field and even reduced visual acuity. To achieve this drop in pressure, there are, of course, hypotonizing eye drops, trabeculoplasty with Laser Selecta (SLT) or filtering surgery (trabeculectomy, deep non-perforating sclerectomy, insertion of drainage devices). Laser Selecta specifically targets pigmented trabecular meshwork cells without damaging adjacent structures, and is thought to act via three mechanisms: distension of Schlemm's canal, reorganization of trabecular meshwork cells and stimulation of extracellular matrix production. Its efficacy has been demonstrated in several studies, with a 20-30% reduction in intraocular pressure in patients who have never undergone surgery. Few studies have investigated the efficacy of SLT in patients who have already undergone filtering surgery. The aim of this study is therefore to determine the efficacy of SLT in previously operated patients whose intraocular pressure remains insufficiently controlled.

Conditions
Glaucoma
Keywords
glaucoma, laser Selecta, trabeculectomy
Medical subject headings
Glaucoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of the intraocular pressure after surgery

    Intraocular pressure is measured before procedure , 1 month, 6months and 12 months after procedure

    Measured: 12 months

Secondary outcomes (4)

  1. Average change of the intraocular pressure after procedure depending of the initial IOP

    Intraocular pressure is measured before procedure , 1 month, 6months and 12 months.

    average IOP decrease is calculated for the group of patients with an initial IOP >21mmHg and for the group with an initial IOP<21mmHg

    Measured: 12 months

  2. Average change of the intraocular pressure after procedure depending on the delay between filtering surgery and the Selecta Laser procedure.

    Intraocular pressure is measured before procedure , 1 month, 6months and 12 months.

    average IOP decrease is calculated for the group of patients with a less than 1 year between filtering surgery and SLT , the group with a period of 1 to 5 years between filtering surgery and SLT and the group with more than 5 year inbetween.

    Measured: 12 months

  3. Average change of the intraocular pressure after procedure depending on the type of filtering surgery

    Intraocular pressure is measured before procedure , 1 month, 6months and 12 months.

    average IOP decrease is calculated for each type of filtering surgery : trabeculectomy or, deep non-perforating sclerectomy, or insertion of drainage devices

    Measured: 12 months

  4. Average change of the intraocular pressure after procedure depending on the type of glaucoma

    Intraocular pressure is measured before procedure , 1 month, 6months and 12 months.

    average IOP decrease is calculated for each type of glaucoma : primary open-angle glaucoma, or exfoliative glaucoma or pigmentary glaucoma

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2019
  4. Study completion15 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05900063
Sponsor's protocol ID
SLT
Acronym
SLT
Status last verified
Jun 2023
First submitted
2 Jun 2023
Last updated
29 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. doi: 10.1016/s0014-4835(05)80093-4.

    PubMed 7789416

  • Nagar M, Luhishi E, Shah N. Intraocular pressure control and fluctuation: the effect of treatment with selective laser trabeculoplasty. Br J Ophthalmol. 2009 Apr;93(4):497-501. doi: 10.1136/bjo.2008.148510. Epub 2008 Dec 23.

    PubMed 19106150

  • Zhang H, Yang Y, Xu J, Yu M. Selective laser trabeculoplasty in treating post-trabeculectomy advanced primary open-angle glaucoma. Exp Ther Med. 2016 Mar;11(3):1090-1094. doi: 10.3892/etm.2015.2959. Epub 2015 Dec 29.

    PubMed 26998042

  • Sharpe RA, Kammerdiener LL, Williams DB, Das SK, Nutaitis MJ. Efficacy of selective laser trabeculoplasty following incisional glaucoma surgery. Int J Ophthalmol. 2018 Jan 18;11(1):71-76. doi: 10.18240/ijo.2018.01.13. eCollection 2018.

    PubMed 29375994

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the intraocular pressure after surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05900063, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
SLT Clinical Trial NCT05900063 | AzTrials