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

• ClinicalTrials.gov Identifier: NCT05906212
• Recruitment Status: Active, not recruiting
• First Posted: June 15, 2023
• Last Update Posted: June 15, 2023
• Sponsor: Shahid Beheshti University of Medical Sciences
• Information provided by (Responsible Party): Mohammadali Javadi, MD, Shahid Beheshti University of Medical Sciences

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Glaucoma; Cataract	Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule; Procedure: Non-penetrating deep sclerectomy and phacoemulsification	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Use of Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification: A Randomized Clinical Trial
• Actual Study Start Date: May 16, 2023
• Estimated Primary Completion Date: May 16, 2024
• Estimated Study Completion Date: June 16, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule; 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.	Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule; This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.
Active Comparator: Non-penetrating deep sclerectomy and phacoemulsification; The control group will be undergoing non-penetrating deep sclerectomy and phacoemulsification without any spacer.	Procedure: Non-penetrating deep sclerectomy and phacoemulsification; This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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

Secondary Outcome Measures :

1. The complete success rate at month 3 follow up [ Time Frame: 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.
2. The complete success rate at month 1 follow up [ Time Frame: 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.
3. The complete success rate at month 6 follow up [ Time Frame: 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.
4. The complete success rate at month 12 follow up [ Time Frame: 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.
5. The qualified success rate at month 3 follow up [ Time Frame: 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.
6. The qualified success rate at month 6 follow up [ Time Frame: 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.
7. The qualified success rate at the month 12 follow up [ Time Frame: 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.
8. The qualified success rate at the month 1 follow up [ Time Frame: 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.
9. Change from baseline the number of glaucoma medications at month 1 follow up [ Time Frame: Baseline and month 1 follow up ]
   The number of glaucoma medications will be assessed at baseline and month 1 follow up.
10. Change from baseline the number of glaucoma medications at month 3 follow up [ Time Frame: Baseline and month 3 follow up ]
    The number of glaucoma medications will be assessed at baseline and month 3 follow up.
11. Change from baseline the number of glaucoma medications at month 6 follow up [ Time Frame: Baseline and month 6 follow up ]
    The number of glaucoma medications will be assessed at baseline and month 6 follow up.
12. Change from baseline the number of glaucoma medications at month 12 follow up [ Time Frame: Baseline and month 12 follow up ]
    The number of glaucoma medications will be assessed at baseline and month 12 follow up.
13. Change from baseline the best-corrected visual acuity at month 6 follow up [ Time Frame: Baseline and month 6 follow up ]
    The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 6 follow up.
14. Change from baseline the best-corrected visual acuity at month 12 follow up [ Time Frame: Baseline and month 12 follow up ]
    The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 12 follow up.
15. Complications at month 1 follow up [ Time Frame: Month 1 follow up ]
    The complications of surgery will be assessed at month 1 follow up.
16. Complications at month 3 follow up [ Time Frame: Month 3 follow up ]
    The complications of surgery will be assessed at month 3 follow up.
17. Complications at month 6 follow up [ Time Frame: Month 6 follow up ]
    The complications of surgery will be assessed at month 6 follow up.
18. Complications at month 12 follow up [ Time Frame: Month 12 follow up ]
    The complications of surgery will be assessed at month 12 follow up.
19. 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 1 follow up
20. 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 3 follow up
21. 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 6 follow up
22. Need to postoperative needling and laser goniopuncture at month 12 follow up [ Time Frame: Month 12 follow up ]
    Need to postoperative needling and laser goniopuncture at month 12 follow up

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria

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

Exclusion criteria

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

Contacts and Locations

Locations

Iran, Islamic Republic of

Ophthalmic Research Center

Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

More Information

• Responsible Party: Mohammadali Javadi, MD, Head of Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT05906212
• Other Study ID Numbers: 14021
• First Posted: June 15, 2023
• Last Update Posted: June 15, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cataract; Eye Diseases; Lens Diseases