Clinical trial NCT04334473: IOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls
Official title: Intraocular Pressure and Ocular Biometrics Changes After Phacoemulsification in Glaucomatous Patients and Age Matched Controls, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Cataract
Keywords: Ocular bio-metrics
Anterior chamber depth
UBM
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants are assigned to the same interventions. All will undergo pre- \& postoperative assessment, cataract surgery.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraocular pressure change
timeFrame: 4 weeks
measure: ocular bio-metrics change
timeFrame: 4 weeks
Secondary outcomes:
measure: Phacoemulsification as treatment to glaucoma
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo university
Study officials:
affiliation: Cairo University
name: Karim A Raafat, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.4274/tjo.92604. Epub 2016 Jun 6.
citation: Melancia D, Abegao 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.
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: 10.1167/iovs.15-17926.
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 Exp Ophthalmol. 2015 May;253(5):773-8. doi: 10.1007/s00417-015-2936-z. Epub 2015 Feb 3.