A clinical trial to evaluate the safety and effectiveness of the corneo-capsular protection system (CCPS - Shamil Device) in protecting the eye during cataract surgery

A randomized, double-blind clinical trial evaluating the efficacy and safety of the the corneo-capsular protection system (CCPS - Shamil Device) compared to standard care in cataract surgery, with primary outcomes of corneal endothelial protection and posterior capsule integrity

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13265494

Enrollment

120

Registered

2024-10-11

Start date

2024-09-01

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular protection and prevention of surgical complications in cataract surgery by using the CCPS (Corneo-Capsular Protection System) "Shamil Device". Eye Diseases

Interventions

Randomisation: - Participants will be randomly allocated to one of the four groups (TPG, CDOG, CFOG, or CG). - A sealed envelope method will be used to ensure randomization. - The study will be conduc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 50 years or older undergoing cataract surgery 2. Diagnosed with age-related cataract requiring surgical intervention 3. Good general health, with no severe systemic illnesses that could affect surgical outcomes 4. Able to provide informed consent 5. Willing and able to attend follow-up appointments at Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery

Exclusion criteria

Exclusion criteria: 1. History of previous intraocular surgery or trauma in the eye undergoing cataract surgery 2. Presence of any corneal disease that could interfere with the outcome of surgery 3. Uncontrolled glaucoma or other severe ocular conditions that may affect the surgical results 4. Allergy or hypersensitivity to materials used in the intraocular lens or surgical instruments 5. Pregnancy or breastfeeding 6. Inability to provide informed consent or comply with the follow-up schedule 7. Significant systemic diseases (e.g., uncontrolled diabetes or cardiovascular disease) that could interfere with recovery or increase surgical risk

Design outcomes

Primary

Measure	Time frame
1. Corneal endothelial cell density is measured using specular microscopy at baseline (pre-surgery), Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery 2. Status of the posterior capsule and anterior chamber is assessed via slit-lamp biomicroscopy at the same time points: Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery	—

Secondary

Measure	Time frame
1. Visual acuity measured using a Snellen chart at baseline, Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery 2. Intraocular pressure (IOP) measured using a tonometer at baseline, Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery 3. Incidence of posterior capsule opacification (PCO) assessed via slit-lamp biomicroscopy at Day 30 (J+30) and Day 60 (J+60) post-surgery 4. Postoperative complications, such as inflammation, assessed via slit-lamp biomicroscopy at Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery 5. Corneal edema and corneal thickness measured using slit-lamp biomicroscopy and pachymetry at Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery	—

Measure

Time frame

1. Visual acuity measured using a Snellen chart at baseline, Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery 2. Intraocular pressure (IOP) measured using a tonometer at baseline, Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery 3. Incidence of posterior capsule opacification (PCO) assessed via slit-lamp biomicroscopy at Day 30 (J+30) and Day 60 (J+60) post-surgery 4. Postoperative complications, such as inflammation, assessed via slit-lamp biomicroscopy at Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery 5. Corneal edema and corneal thickness measured using slit-lamp biomicroscopy and pachymetry at Day 1 (J+1), Day 8 (J+8), Day 30 (J+30), and Day 60 (J+60) post-surgery

—

Countries

Morocco

Contacts

Public ContactShamil Louaya

z.lemkhente@uiz.ac.ma+212 661086320

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026