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

Cataract Clinical Trial

Official title:

Intraocular Pressure and Ocular Biometrics Changes After Phacoemulsification in Glaucomatous Patients and Age Matched Controls, Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334473
• Other study ID #: N-45-2019
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 1, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Procedure:
• phacoemulsification and Intraocular lens implantation
Standartd surgical procedure with small incision to remove catarct using ultrasound waves. it can be done by topica, local or general anaesthesia acoording to patients general fitness and preference.

Diagnostic Test:
• Ultrasound Biomicrosopy (UBM)
A diagnostic test using ultrasound waves to evaluate the anterior chamber depth, angle and lens vault.

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Mai Nasser Abd Elmohsen

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Elgin U, Sen E, Simsek T, Tekin K, Yilmazbas P. Early Postoperative Effects of Cataract Surgery on Anterior Segment Parameters in Primary Open-Angle Glaucoma and Pseudoexfoliation Glaucoma. Turk J Ophthalmol. 2016 Jun;46(3):95-98. Epub 2016 Jun 6. — View Citation

Hsu CH, Kakigi CL, Lin SC, Wang YH, Porco T, Lin SC. Lens Position Parameters as Predictors of Intraocular Pressure Reduction After Cataract Surgery in Nonglaucomatous Patients With Open Angles. Invest Ophthalmol Vis Sci. 2015 Dec 1;56(13):7807-7813. doi: — View Citation

Man X, Chan NC, Baig N, Kwong YY, Leung DY, Li FC, Tham CC. Anatomical effects of clear lens extraction by phacoemulsification versus trabeculectomy on anterior chamber drainage angle in primary angle-closure glaucoma (PACG) patients. Graefes Arch Clin Ex — View Citation

Melancia D, Abegão Pinto L, Marques-Neves C. Cataract surgery and intraocular pressure. Ophthalmic Res. 2015;53(3):141-8. doi: 10.1159/000377635. Epub 2015 Mar 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure change	intraocular pressure measurement by Goldman's applanation tonometr	4 weeks
Primary	ocular bio-metrics change	anterior chamber angle angle opening distance and anterior chamber depth change	4 weeks
Secondary	Phacoemulsification as treatment to glaucoma	intraocular pressure decrease after surgery in glaucoma patients	4 weeks