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

NCT05906212 | Unknown

• 1 other identifier: 14021
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Cataract

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (22)

• The complete success rate at month 3 follow up

  Month 3 follow up

• The complete success rate at month 1 follow up

  Month 1 follow up

• The complete success rate at month 6 follow up

  Month 6 follow up

• The complete success rate at month 12 follow up

  Month 12 follow up

• The qualified success rate at month 3 follow up

  Month 3 follow up

Study Arms (2)

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.

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.

Procedure: Non-penetrating deep sclerectomy and phacoemulsification

Interventions

Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule PROCEDURE

This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.

Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule

Non-penetrating deep sclerectomy and phacoemulsification PROCEDURE

This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.

Non-penetrating deep sclerectomy and phacoemulsification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

Location

MeSH Terms

Conditions

Glaucoma; Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmic Research Center

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 15, 2023
• Study Start: May 16, 2023
• Primary Completion: May 16, 2024
• Study Completion: June 16, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)