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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma; Cataract
• Intervention / Treatment: Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule; Procedure: Non-penetrating deep sclerectomy and phacoemulsification

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Ophthalmic Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Baselines and month 12 follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and month 12 follow up
Complications at month 1 follow up	The complications of surgery will be assessed at month 1 follow up.	Month 1 follow up
Complications at month 3 follow up	The complications of surgery will be assessed at month 3 follow up.	Month 3 follow up
Complications at month 6 follow up	The complications of surgery will be assessed at month 6 follow up.	Month 6 follow up
Complications at month 12 follow up	The complications of surgery will be assessed at month 12 follow up.	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	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	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	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	Month 12 follow up

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Estimated): May 16, 2024
• Study Completion (Estimated): June 16, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 14021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No