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Cataract clinical trials

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NCT ID: NCT01818037 Completed - Clinical trials for Microphthalmos With Congenital Cataracts

Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos

Start date: January 2003
Phase: N/A
Study type: Observational

Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding. In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus, glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of cataract surgery. In our previous study, the investigators examined the intraoperative performance and postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients before their first birthday. At 1 year, the postoperative results showed that good visual outcomes could be obtained in microphthalmic eyes. Since only a few studies have reported outcomes, and that too only short term of cataract surgery on microphthalmic eyes, in this prospective observational study we evaluated the long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators examined the outcomes, complication rates, influence of age at surgery on pattern of axial growth and central corneal thickness and visual and orthoptic assessment in these eyes.

NCT ID: NCT01808560 Completed - Dry Eye Syndrome Clinical Trials

Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this pilot feasibility study is to assess whether treating meibomian gland dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual quality and ocular comfort after cataract surgery.

NCT ID: NCT01808547 Completed - Ocular Inflammation Clinical Trials

Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.

NCT ID: NCT01800708 Completed - Cataract Clinical Trials

Cataract Surgery With Intracameral Triamcinolone in Infants

Start date: January 2010
Phase: N/A
Study type: Interventional

The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone. This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.

NCT ID: NCT01786356 Completed - Cataract Clinical Trials

Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two IOLs: Hoya iMics Y-60H vs. Bausch&Lomb MI60 (MIMI)

Start date: March 2008
Phase: N/A
Study type: Interventional

Age-related cataract is the main cause of impaired vision in the elderly population worldwide. The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications. The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag. Modifications in IOL design and material lead to a decrease in the incidence of PCO. During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design. The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 4 years.

NCT ID: NCT01778998 Completed - Cataract Clinical Trials

Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study

INCISIONS
Start date: February 2012
Phase: N/A
Study type: Interventional

One of the most recent advances in cataract surgery is microincisional phacoemulsification (MICS). Through small incisions of 2.0 mm and less the lens material is emulsified either bimanually or with a thin single coaxial hand-piece. The possible advantages are lower induced corneal astigmatism1, 2, possibly a lower incidence of infection due to higher resistance of the wound to deformation3 and a lower risk of complications such as iris prolapse during surgery in patients at risk such as with intraoperative floppy iris syndrome (IFIS). Additional factors that have to be taken into account are the construction and the position of the incision and the influence of the extraocular force on the wound morphology.4 Another effect that may influence the wound architecture is stromal hydration at the end of surgery.5 Wound architecture has recently been assessed6-9 using optical coherence tomography. Elkady et al.10 observed the wound architecture in MICS cases focusing on corneal thickness and the incision angle. However, none of these studies observed the effect of the wound architecture on post-operative astigmatism. Furthermore, all observations in the past have been performed in the post-operative period only and information concerning the wound architecture intra-operatively is missing. A recently launched CE-marked intra-operative OCT allows observing the wound architecture intra-operatively. One aim of the study is to assess the influence of the intra-operative wound architecture using a similar grading system as used by Calladine and Packard (2007)7 on the resistance to deformation of the wound and the surgically induced astigmatism in MICS and small incision cataract surgery (SICS). In a second part of this exploratory study the effect of a hinged incision with a pre-cut should be assessed along the same line

NCT ID: NCT01774474 Completed - Diabetes Mellitus Clinical Trials

PRevention of Macular EDema After Cataract Surgery

PREMED
Start date: July 10, 2013
Phase: Phase 3
Study type: Interventional

Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. The investigators will perform a large RCT with the aim to provide more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus (DM).

NCT ID: NCT01769313 Completed - Cataract Clinical Trials

A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery

Start date: January 2013
Phase: Phase 4
Study type: Interventional

This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized, prospective, single-center, multi-surgeon, investigator masked study to investigate whether the femtolaser cataract surgery causes any significant differences in the resulting Intra Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of mass.

NCT ID: NCT01767012 Completed - Diabetes Clinical Trials

Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties

POL
Start date: August 2010
Phase: Phase 4
Study type: Interventional

Modern phacoemulsification techniques have made cataract surgery safe and efficient over the past several decades. Although the phacoemulsification procedure has improved greatly, cataract surgery still involves trauma. One of the surgical traumas during cataract surgery is the direct trauma of the anterior uvea, resulting in a later chronic immune reaction of the uvea to the implanted intraocular lens (IOL). 1 The breakdown of the blood-aqueous barrier (a measure of the uveal reaction) clinically presents as flare in the anterior chamber. 2 Petternel et al. 3 explained that the protein content of the aqueous humor may mainly arise from the iris root and iris vessels in the anterior chamber. The peak of this flare and cell intensity in the anterior chamber was shown to be reached during the first two days after cataract surgery 4 and flare levels were back to the preoperative values about one year after cataract surgery. 5, 6 Influencing factors are surgical technique 7, perioperative treatment 8, IOL biomaterial and design 9 and host reaction to the IOL. In this study the otherwise same IOL concerning material and design, but one with a new surface modification will be compared to assess the influence on aqueous flare and cell intensity in the anterior chamber. The Polylens (Polytech, Rossdorf, Germany) is a hydrophobic acrylic single-piece open-loop IOL and is available with the standard surface and a novel modified surface. To assess the efficacy of the newly modified surface of the Polylens IOL compared to the same IOL without a modified surface concerning flare and cell intensity in the anterior chamber as well as cellular components on the IOL surface and lens epithelial out-growth from the rhexis after cataract surgery in eyes of patients with diabetes mellitus and pseudoexfoliation syndrome, which typically have a higher incidence of post-operative intra-ocular inflammation.

NCT ID: NCT01763151 Completed - Cataract Clinical Trials

Comparison of Toric IOL Implantation and Opposite Clear Corneal Incision During Cataract Surgery to Correct Corneal Astigmatism

Start date: September 2010
Phase: Phase 4
Study type: Interventional

With increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more widely to cataract surgery. Originally toric IOLs were used mainly for patients with high degrees of astigmatism, especially after corneal surgical procedures such as penetrating keratoplasty. Since a couple of years, toric IOLs are available from numerous manufacturers to correct lower amounts of astigmatism which are much more prevalent with about 30% having a corneal astigmatism of 0.75D or more in the cataract population. This should result in less spectacle dependence of patients due to the astigmatic correction. The alternative method to reduce corneal astigmatism as part of cataract surgery is to make incisions on the steeper axis of the cornea such as limbal relaxing incisions or an additional clear corneal incision opposite (OCCI) to the main cataract opening. These techniques are in use since more than 2 decades and are widely used in clinical routine. As with toric IOLs, precise alignment of the cuts with the axis of astigmatism is essential. The disadvantage of the incisional techniques is the variability of the effect between patients since it depends on factors such as the extent of scaring of the cuts after surgery as well as corneal thickness. The main advantage is the simplicity of the technique and the lower cost. Aim of this study is to compare toric IOL implantation and opposite clear corneal incision during cataract surgery to correct corneal astigmatism.