IOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls

Not Applicable

Completed

• Conditions: Cataract; Glaucoma
• Interventions: Procedure: phacoemulsification and Intraocular lens implantation; Diagnostic Test: Ultrasound Biomicrosopy (UBM)

• Registration Number: NCT04334473
• Lead Sponsor: Mai Nasser Abd Elmohsen

Brief Summary

Effect of phacoemulsification on intraocular pressure has been studied with variable results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. In our study we aim at establishing a quantitative relationship between preoperative ocular biometrics and postoperative intraocular pressure change and comparing this relationship in glaucomatous and non-glaucomatous eyes.

Detailed Description

All patients will have the anterior chamber angle assessed by indentation gonioscopy preoperatively. Anterior Chamber Depth \& lens thickness will be measured by Optical Biometry (lenstar 900) as well as measurement of the angle \& lens vault using the Ultrasound Biomicrosopy (UBM) before and 1 month after cataract surgery. IOP will be measured pre- \& postoperatively on day 7 and 30. Possible Risk (s): Risks of surgery(hemorrhage, endophthalmitis), Risks for investigations: minimal risk of infection To minimize the risk of infection: adherence to pre-\& intraoperative infection-control measures, postoperative UBM is to be done at 1 month.

Study Timeline

• Study Start: 2019-09-20
• Primary Completion: 2020-03-15
• Status Verified: 2020-04
• Study Completion: 2020-04-01
• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-02
• Last Update Submitted: 2020-04-02
• Study First Posted: 2020-04-06
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Age 40-70 years.
• Glaucomtous and nonglaucomatous participants with visually significant cataracts.
• Best-corrected visual acuity (BCVA) equal to or worse than 6/12.
• patients candidates for standard cataract surgeries without adjunctive procedure (e.g., pupil stretching or iris hooks).

Exclusion Criteria

• Major intraoperative or postoperative complications from cataract surgery
• Peripheral anterior synechiae (PAS) detected by indentation gonioscopy.
• Uveitis, severe retinal diseases, or congenital Anomalies.
• History of ocular trauma or any intraocular Surgery. ocular trauma or any intraocular Surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cataract patients	Ultrasound Biomicrosopy (UBM)	Patients having cataract candidates for phacoemulsification with or without glaucoma are prepared to do cataract surgery with preoperative and postoperative assessment of intraocular pressure and ocular bio-metrics using UBM.
cataract patients	phacoemulsification and Intraocular lens implantation	Patients having cataract candidates for phacoemulsification with or without glaucoma are prepared to do cataract surgery with preoperative and postoperative assessment of intraocular pressure and ocular bio-metrics using UBM.

Primary Outcome Measures

Name	Time	Method
ocular bio-metrics change	4 weeks	anterior chamber angle angle opening distance and anterior chamber depth change
Intraocular pressure change	4 weeks	intraocular pressure measurement by Goldman's applanation tonometr

Secondary Outcome Measures

Name	Time	Method
Phacoemulsification as treatment to glaucoma	4 weeks	intraocular pressure decrease after surgery in glaucoma patients

Trial Locations

Locations (1)

Faculty of medicine, Cairo university; 🇪🇬 Cairo, Egypt