GlaucomaNCT05906212

Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification

A study testing Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule and Non-penetrating deep sclerectomy and phacoemulsification in people with Glaucoma and Cataract, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Cataract
What is being tested?: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule and Non-penetrating deep sclerectomy and phacoemulsification
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteIran
Study dates: 16 May 2023to 16 Jun 2024
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

Patients with concomitant uncontrolled glaucoma and significant cataract
Progression in glaucoma despite medical treatment
Age more than 18 years old

Who cannot join

Prior ocular surgery
Neovascular glaucoma or uveitic glaucoma
Compromised ocular surface or insufficient conjunctiva

Trial locations and contacts

1 site in 1 country.

Iran1 site

Ophthalmic Research Center
Tehran

Other trials in Iran

About this study

Official title: Use of Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification: A Randomized Clinical Trial

In this randomized clinical trial, patients with concomitant glaucoma and cataract candidate for non-penetrating deep sclerectomy (NPDS) and phacoemulsification (PE) and subtenon mitomycin injection will be enrolled. Patients will randomly be allocated to two groups ["NPDS and PE and autotransplantation of human anterior lens capsule (ALC)" and "NPDS and PE" alone]. Exclusion criteria will be the patients with prior ocular surgery, neovascular glaucoma, uveitis, or compromised ocular surface. The intervention group will be undergoing NPDS and PE with the use of an ALC as the spacer in the intrascleral lake. The control group will be undergoing NPDS and PE without any spacer. The primary outcome will be intraocular pressure measured on days 1, 3, 7, months 1, 3, 6, and 12. The secondary outcomes will be surgical success rate (complete and qualified), the number of glaucoma medications, best-corrected visual acuity, surgical complications, and the need for needling and laser goniopuncture measured at the same intervals. The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication. The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication.

Conditions: Glaucoma, Cataract
Being tested: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule, Non-penetrating deep sclerectomy and phacoemulsification
Medical subject headings: Glaucoma, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsuleProcedure or surgery
This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.
Non-penetrating deep sclerectomy and phacoemulsificationProcedure or surgery
This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.

Study groups in NCT05906212
Study group	Role	What they receive
Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule	Experimental	The intervention group will be undergoing non-penetrating deep sclerectomy and phacoemulsification with the use of an autotransplantation of the human anterior lens capsule as the spacer in the intrascleral lake. Receives: Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule
Non-penetrating deep sclerectomy and phacoemulsification	Active comparator	The control group will be undergoing non-penetrating deep sclerectomy and phacoemulsification without any spacer. Receives: Procedure: Non-penetrating deep sclerectomy and phacoemulsification

What is being measured

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

Change from baseline intraocular pressure at month 1 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 1 follow up
Measured: Baselines and month 1 follow up
Change from baseline intraocular pressure at month 3 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 3 follow up
Measured: Baselines and month 3 follow up
Change from baseline intraocular pressure at month 6 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 6 follow up
Measured: Baselines and month 6 follow up
Change from baseline intraocular pressure at month 12 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 12 follow up
Measured: Baselines and month 12 follow up

Secondary outcomes (22)

The complete success rate at month 3 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 3 follow up.
Measured: Month 3 follow up
The complete success rate at month 1 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 1 follow up.
Measured: Month 1 follow up
The complete success rate at month 6 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 6 follow up.
Measured: Month 6 follow up
The complete success rate at month 12 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 12 follow up.
Measured: Month 12 follow up
The qualified success rate at month 3 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 3 followup.
Measured: Month 3 follow up
The qualified success rate at month 6 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 6 followup.
Measured: Month 6 follow up
The qualified success rate at the month 12 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 12 followup.
Measured: Month 12 follow up
The qualified success rate at the month 1 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 1 followup.
Measured: Month 1 follow up
Change from baseline the number of glaucoma medications at month 1 follow up
The number of glaucoma medications will be assessed at baseline and month 1 follow up.
Measured: Baseline and month 1 follow up
Change from baseline the number of glaucoma medications at month 3 follow up
The number of glaucoma medications will be assessed at baseline and month 3 follow up.
Measured: Baseline and month 3 follow up
Change from baseline the number of glaucoma medications at month 6 follow up
The number of glaucoma medications will be assessed at baseline and month 6 follow up.
Measured: Baseline and month 6 follow up
Change from baseline the number of glaucoma medications at month 12 follow up
The number of glaucoma medications will be assessed at baseline and month 12 follow up.
Measured: Baseline and month 12 follow up
Change from baseline the best-corrected visual acuity at month 6 follow up
The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 6 follow up.
Measured: Baseline and month 6 follow up
Change from baseline the best-corrected visual acuity at month 12 follow up
The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 12 follow up.
Measured: Baseline and month 12 follow up
Complications at month 1 follow up
The complications of surgery will be assessed at month 1 follow up.
Measured: Month 1 follow up
Complications at month 3 follow up
The complications of surgery will be assessed at month 3 follow up.
Measured: Month 3 follow up
Complications at month 6 follow up
The complications of surgery will be assessed at month 6 follow up.
Measured: Month 6 follow up
Complications at month 12 follow up
The complications of surgery will be assessed at month 12 follow up.
Measured: Month 12 follow up
Need to postoperative needling and laser goniopuncture at month 1 follow up
Need to postoperative needling and laser goniopuncture at month 1 follow up
Measured: Month 1 follow up
Need to postoperative needling and laser goniopuncture at month 3 follow up
Need to postoperative needling and laser goniopuncture at month 3 follow up
Measured: Month 3 follow up
Need to postoperative needling and laser goniopuncture at month 6 follow up
Need to postoperative needling and laser goniopuncture at month 6 follow up
Measured: Month 6 follow up
Need to postoperative needling and laser goniopuncture at month 12 follow up
Need to postoperative needling and laser goniopuncture at month 12 follow up
Measured: Month 12 follow up

Timeline

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

16 May 202316 Jun 2024

First posted15 Jun 2023
Study start16 May 2023
Primary completion16 May 2024 (estimated)
Study completion16 Jun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GlaucomaStudies of the same condition, open and under way.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05906212
Sponsor's protocol ID: 14021
Status last verified: Jun 2023
First submitted: 16 May 2023
Last updated: 15 Jun 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05906212
Acronym / sponsor ID: 14021
Conditions: Glaucoma, Cataract
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 66 participants (actual)
Lead sponsor: Shahid Beheshti University of Medical SciencesUniversity, hospital or other
Study start: 16 May 2023 (actual)
Primary completion: 16 May 2024 (estimated)
Study completion: 16 Jun 2024 (estimated)
First posted: 15 Jun 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule	Experimental	Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsuleThe intervention group will be undergoing non-penetrating deep sclerectomy and phacoemulsification with the use of an autotransplantation of the human anterior lens capsule as the spacer in the intrascleral lake.
Non-penetrating deep sclerectomy and phacoemulsification	Active comparator	Procedure: Non-penetrating deep sclerectomy and phacoemulsificationThe control group will be undergoing non-penetrating deep sclerectomy and phacoemulsification without any spacer.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with concomitant uncontrolled glaucoma and significant cataract
Progression in glaucoma despite medical treatment
Age more than 18 years old

Key exclusion criteria (3 listed)

Prior ocular surgery
Neovascular glaucoma or uveitic glaucoma
Compromised ocular surface or insufficient conjunctiva

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
Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsuleThis group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.	Procedure or surgery	Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule
Non-penetrating deep sclerectomy and phacoemulsificationThis group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.	Procedure or surgery	Non-penetrating deep sclerectomy and phacoemulsification

Primary outcome

Change from baseline intraocular pressure at month 1 follow up
Time frame: Baselines and month 1 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 1 follow up
Change from baseline intraocular pressure at month 3 follow up
Time frame: Baselines and month 3 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 3 follow up
Change from baseline intraocular pressure at month 6 follow up
Time frame: Baselines and month 6 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 6 follow up
Change from baseline intraocular pressure at month 12 follow up
Time frame: Baselines and month 12 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 12 follow up

22 secondary outcomes

The complete success rate at month 3 follow up
Time frame: Month 3 follow up
The complete success rate at month 1 follow up
Time frame: Month 1 follow up
The complete success rate at month 6 follow up
Time frame: Month 6 follow up
The complete success rate at month 12 follow up
Time frame: Month 12 follow up
The qualified success rate at month 3 follow up
Time frame: Month 3 follow up
The qualified success rate at month 6 follow up
Time frame: Month 6 follow up
The qualified success rate at the month 12 follow up
Time frame: Month 12 follow up
The qualified success rate at the month 1 follow up
Time frame: Month 1 follow up
Change from baseline the number of glaucoma medications at month 1 follow up
Time frame: Baseline and month 1 follow up
Change from baseline the number of glaucoma medications at month 3 follow up
Time frame: Baseline and month 3 follow up
Change from baseline the number of glaucoma medications at month 6 follow up
Time frame: Baseline and month 6 follow up
Change from baseline the number of glaucoma medications at month 12 follow up
Time frame: Baseline and month 12 follow up
Change from baseline the best-corrected visual acuity at month 6 follow up
Time frame: Baseline and month 6 follow up
Change from baseline the best-corrected visual acuity at month 12 follow up
Time frame: Baseline and month 12 follow up
Complications at month 1 follow up
Time frame: Month 1 follow up
Complications at month 3 follow up
Time frame: Month 3 follow up
Complications at month 6 follow up
Time frame: Month 6 follow up
Complications at month 12 follow up
Time frame: Month 12 follow up
Need to postoperative needling and laser goniopuncture at month 1 follow up
Time frame: Month 1 follow up
Need to postoperative needling and laser goniopuncture at month 3 follow up
Time frame: Month 3 follow up
Need to postoperative needling and laser goniopuncture at month 6 follow up
Time frame: Month 6 follow up
Need to postoperative needling and laser goniopuncture at month 12 follow up
Time frame: Month 12 follow up

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 3 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 15 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 Iran. 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?

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 from baseline intraocular pressure at month 1 follow up (time frame: Baselines and month 1 follow up). The study lists 4 primary outcomes in all. 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 NCT05906212.

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 15 Jun 2023.