Treatment of Refractory GlaucomaNCT05437614
Comparison of Outcome and Effectiveness Between Micropulse Diode Laser Cyclophotocoagulation and Cyclocryoablation in Treatment of Refractory Glaucoma
A study testing Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma and Cyclocryoablation in treatment of refractory Glaucoma in people with Treatment of Refractory Glaucoma, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
laucoma having bad prognosis after maximally tolerated medication,glaucoma that fails after filtering operations, neovascular glaucoma, glaucoma following vitrectomy and glaucoma secondary to uveitis etc. is collectively termed as refractory glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Refractory Glaucoma
- What is being tested?
- Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma and Cyclocryoablation in treatment of refractory Glaucoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 1 Mar 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive diagnosis of refractory glaucoma
- Poor visual acuity: Hand movements or less
- Age ≥ 18 years
- Intraocular pressure ≥ 21 mmHg
- Signed informed consent
Who cannot join
- Eye surgery performed over the last 3 months
- Eye inflammation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Holy Family Hospital
Rawalpindi, Punjab Province, 46000
Mariam Noor, MBBS, 923314512003, drmariam133@gmail.com
About this study
laucoma having bad prognosis after maximally tolerated medication,glaucoma that fails after filtering operations, neovascular glaucoma, glaucoma following vitrectomy and glaucoma secondary to uveitis etc. is collectively termed as refractory glaucoma. For such glaucoma patients, cyclodestructive procedures are often used to reduce IOP, as well as to relieve ocular and periocular pain. Recently,diode laser transscleral cyclophotocoagulation has proved to be an effective method for the treatment of refractory glaucoma and it has become a standard treatment for refractory glaucoma.(Yu, Q., Liang, Y., Ji, F. and Yuan, Z.,et al 2020. ) In previous articles, little is known about the long-term outcomes of micropulse diode laser cyclophotocoagulation and cyclocryotherapy. Discrepancies in the results of several large observational analyses have introduced further ambiguity on the role of micropulse diode laser cyclophotocoagulation and cyclocryotherapy.The mechanism of transcleral cyclophotocoagulation IOP lowering in refractory glaucoma is not well understood. In this study, we perform cyclocryoablation and micropulse diode laser cyclophotocoagulation in patients with refractory glaucoma and report the outcomes / mechanism of IOP control using this new surgical paradigm. The objective of our project is to assess the end result and outcome of the role of micropulse diode laser cyclophotocoagulation and cyclocryotherapy.We aim to evaluate the comparison between micropulse diode laser cyclophotocoagulation and cyclocryotherapy.
Only those subjects will be recruited who provide written informed consent. Patients are diagnosed on bases of tonometry, gonioscopy, ophthalmoscopy, perimetry. Patients' age, gender, type of glaucoma, number of diode laser treatment sessions, postoperative complications, number of hypotensive medications required to control IOP, and best corrected visual acuity (BCVA) will be evaluated. The criteria for success will be defined as postoperative IOP <21 mmHg or >20% decrease in IOP with or without additional medical treatment.
- Conditions
- Treatment of Refractory Glaucoma
- Being tested
- Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma, Cyclocryoablation in treatment of refractory Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse diode laser cyclophotocoagulation in treatment of refractory GlaucomaProcedure or surgery
Treatment of refractory Glaucoma by Micropulse diode laser cyclophotocoagulation
Cyclocryoablation in treatment of refractory GlaucomaProcedure or surgery
Treatment of refractory Glaucoma by cyclocryoablation
| Study group | Role | What they receive |
|---|---|---|
| Treatment of refractory glaucoma using Micropulse diode laser cyclophotocoagulation | Active comparator | Not described Receives: Procedure: Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma |
| Treatment of refractory glaucoma using cyclocryoablation | Active comparator | Not described Receives: Procedure: Cyclocryoablation in treatment of refractory Glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
Hypotony, Fibrinous uveitis, Cystoid macular edema
Measured: 1 year
Reduced IOP
Reduction in IOP to less than 21 mmHg medications required to control IOP
Measured: 1 year
Decrease in number of hypotensive drugs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Mar 2022
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Refractory GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Noor, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437614
- Sponsor's protocol ID
- UniversityHSL786
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome and Effectiveness Between Micropulse Diode Laser Cyclophotocoagulation and Cyclocryoablation in Treatment of Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT05437614
- Acronym / sponsor ID
- UniversityHSL786
- Conditions
- Treatment of Refractory Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
laucoma having bad prognosis after maximally tolerated medication,glaucoma that fails after filtering operations, neovascular glaucoma, glaucoma following vitrectomy and glaucoma secondary to uveitis etc. is collectively termed as refractory glaucoma. For such glaucoma patients, cyclodestructive procedures are often used to reduce IOP, as well as to relieve ocular and periocular pain. Recently,diode laser transscleral cyclophotocoagulation has proved to be an effective method for the treatment of refractory glaucoma and it has become a standard treatment for refractory glaucoma.(Yu, Q., Liang, Y., Ji, F. and Yuan, Z.,et al 2020. ) In previous articles, little is known about the long-term outcomes of micropulse diode laser cyclophotocoagulation and cyclocryotherapy. Discrepancies in the results of several large observational analyses have introduced further ambiguity on the role of micropulse diode laser cyclophotocoagulation and cyclocryotherapy.The mechanism of transcleral cyclophotocoagulation IOP lowering in refractory glaucoma is not well understood. In this study, we perform cyclocryoablation and micropulse diode laser cyclophotocoagulation in patients with refractory glaucoma and report the outcomes / mechanism of IOP control using this new surgical paradigm. The objective of our project is to assess the end result and outcome of the role of micropulse diode laser cyclophotocoagulation and cyclocryotherapy.We aim to evaluate the comparison between micropulse diode laser cyclophotocoagulation and cyclocryotherapy.
Only those subjects will be recruited who provide written informed consent. Patients are diagnosed on bases of tonometry, gonioscopy, ophthalmoscopy, perimetry. Patients' age, gender, type of glaucoma, number of diode laser treatment sessions, postoperative complications, number of hypotensive medications required to control IOP, and best corrected visual acuity (BCVA) will be evaluated. The criteria for success will be defined as postoperative IOP <21 mmHg or >20% decrease in IOP with or without additional medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment of refractory glaucoma using Micropulse diode laser cyclophotocoagulation | Active comparator | Procedure: Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma |
| Treatment of refractory glaucoma using cyclocryoablation | Active comparator | Procedure: Cyclocryoablation in treatment of refractory Glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive diagnosis of refractory glaucoma
- Poor visual acuity: Hand movements or less
- Age ≥ 18 years
- Intraocular pressure ≥ 21 mmHg
- Signed informed consent
Key exclusion criteria (2 listed)
- Eye surgery performed over the last 3 months
- Eye inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micropulse diode laser cyclophotocoagulation in treatment of refractory GlaucomaTreatment of refractory Glaucoma by Micropulse diode laser cyclophotocoagulation | Procedure or surgery | Treatment of refractory glaucoma using Micropulse diode laser cyclophotocoagulation |
| Cyclocryoablation in treatment of refractory GlaucomaTreatment of refractory Glaucoma by cyclocryoablation | Procedure or surgery | Treatment of refractory glaucoma using cyclocryoablation |
Primary outcome
postoperative complications
Time frame: 1 year
Hypotony, Fibrinous uveitis, Cystoid macular edema
Reduced IOP
Time frame: 1 year
Reduction in IOP to less than 21 mmHg medications required to control IOP
Decrease in number of hypotensive drugs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Treatment of Refractory Glaucoma
Recruiting
The Vizio Clinical Study
Refractory Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma and Cyclocryoablation in treatment of refractory Glaucoma in people with Treatment of Refractory Glaucoma, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jun 2022. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Noor, MBBS (923314512003, drmariam133@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2022.